| Manufacturer Performance Reports &
Explant Return Process |
2010
Society Attends First FDA Workshop Reviewing the 510(K) Program (02/26/2010) — The Heart Rhythm Society attended the first public workshop of the U.S. Food & Drug Administration (FDA) working group tasked to reevaluate and potentially modify the 510(k) program. A 510(k) is a premarket submission made to FDA to demonstrate that a Class I, II, and III device can be as safe and effective, that is, substantially equivalent, to a legally marketed device, when the new device is not subject to a Premarket Approval. Learn more »
Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical
On February 4, 2010, the U.S. Food and Drug Administration (FDA) and Thomas Medical Products Inc. notified health care professionals of a Class I Recall of certain lots of Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport, tube-like devices placed into blood vessels to insert pacing or defibrillator wires and catheters into blood vessels. The sheath tip may break off and separate while the sheath is inside a blood vessel, which could cause a blockage and lead to permanent injury or death. Learn more »
Review of the 510(k) Program — First FDA Public Meeting on February 18 (01/28/2010) — In response to increasing criticism toward the pre-market approval process, the Food & Drug Administration (FDA) has convened an internal working group to evaluate and improve the administration quality and consistency of the FDA’s decision-making in the 510(k) program. The internal working group will hold its first public meeting on February 18, where presenters will provide a brief overview of the challenges facing the agency. Learn more »
The Second Annual Sentinel Initiative Public Workshop (01/14/2010) — On January 11, the Heart Rhythm Society attended the Second Annual Sentinel Initiative Public Workshop. At the multi-stakeholder meeting, hosted by the Engelberg Center for Health Care Reform, participants discussed a range of issues, including the recently completed FDA contracts for the development of the Sentinel System and ongoing pilot projects tracking medical product safety. Learn more »
2009
Energy Levels in External Biphasic Defibrillators: Initial Communication (11/05/2009) — The U.S. Food and Drug Administration (FDA) issued the following initial communication "Energy Levels in External Biphasic Defibrillators." FDA is investigating energy levels in external biphasic defibrillators with shocks ≤ 200 J, having received reports of 14 events since 2006 in which a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion. FDA is seeking additional information in order to interpret the significance of these events, and to determine whether FDA activities are advised. Learn more »
FDA to Evaluate Pre-market Approval Process for Medical Devices (10/07/2009) — The FDA recently commissioned the Institute of Medicine to assess its premarket approval process, also known as the 510(k) clearance program for medical devices. The review, expected to cost $1.3 million, will help determine how the program can be improved and will be released in March 2011. Learn more »
2008
Heart Rhythm Society Statement on Device and Lead Reliability and Safety (12/11/08)In response to the perspective “Learning from Our Mistakes? Testing New ICD Technology” by Robert Hauser, MD and Adrian Almquist, MD as well as a corresponding letter from Mitchell Shein and Daniel Schultz from the FDA were published in the December 11, 2008 issue of the New England Journal of Medicine, the Society reiterated its position on the importance of device and lead reliability and safety. Visit the Society's press release collection to learn more »
Society Members Collaborate with the FDA at Pacemaker and ICD Lead Workshop (10/08/2008) — Bruce Wilkoff, MD, FHRS; William Maisel, MD and Andrew Krahn, MD represented the Society as participants in the U.S. Food and Drug Administration’s Workshop on Best Practices for Pacemaker and ICD Lead Postmarket Surveillance on October 2-3, 2008. They emphasized the importance of post-market surveillance, the risk versus benefit of lead extraction for return product analysis, the importance of follow-up and communicating adverse events in a timely manner and benefits of registries and home monitoring systems for reporting essential information in their presentations. Learn more »
Heart Rhythm Society Continues to Influence FDA Risk Advisory Notices (02/29/2008) — On February 29, the Heart Rhythm Society presented a statement from our recommendations in the 2006 Device Performance Policies and Guidelines document during testimony in front of a newly established FDA Risk Communication Advisory Committee. Learn more »
Safety Alerts
For more information about Safety Alerts, please visit the FDA Website.
2009
Physio-Control Inc., LIFEPAK CR Plus Automated External Defibrillators (9/16/09) — FDA notified healthcare professionals of a Class I recall of certain LIFEPAK CR Plus Automated External Defibrillators (AED) manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the affected devices to improperly analyze the heart rhythm and may cause the device to delay or fail to deliver therapy. Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail or fax to 1 (800) FDA-0178. Recall Notice.
FDA Classifies Previously Announced Medtronic Physician Advisory on Small Subset of Kappa and Sigma Pacemakers as Class I Recall (06/10/09) — Medtronic, Inc. announced that the U.S. Food and Drug Administration (FDA) has classified Medtronic’s previously announced physician advisory about a small subset of Kappa® and Sigma® series pacemakers, identified at increased susceptibility for separation of bonded interconnect wires from the electronic circuit, as a Class I recall. Learn more »
Medtronic, Inc. Releases Patient Safety Information (05/18/09) — Specific subsets of Kappa® and Sigma® series pacemakers may fail at a higher than expected rate due to separation of wires that connect the electronic circuit to other pacemaker components. Learn more »
Boston Scientific Product Advisory concerning COGNIS CRT-D and TELOGEN ICD (03/24/2009) — Boston Scientific issued a product advisory on March 23, indicating that inappropriate therapy associated with certain right ventricular (RV) lead complications may occur more frequently if the Respiratory Sensor is programmed On. Learn more »
2008
Possible Malfunction of Implantable Medical Devices by CT Scanning (7/14/2008) — On July 14, 2008 the Food & Drug Administration (FDA) issued notice that the Agency has received a small number of reports of adverse events in which computed tomography (CT) scans may have interfered with pacemakers, ICDs, among other electronic medical devices. Learn more »
2007
Daylight Savings Time Change Three Weeks Earlier— Impact on Implanted Medical Devices (03/10/2007) — The Congressional passage of the Energy Policy Act of 2005 requires the start of Daylight Saving Time to begin on March 11, 2007, rather than April 1, 2007. Learn more about the impact of this time change on implanted medical devices.
2006
Magnets May Pose Serious Risks for Patients with Pacemakers and ICDs (11/30/2006) — Magnets may interfere with the operation of pacemakers and implantable cardioverter defibrillators (ICDs), according to a study published in the December 2006 edition of HeartRhythm. Learn more »
Risk of Electromagnetic Interference with Medical Telemetry Systems Operating in the 460-470 MHz Frequency Bands (01/01/2006) — FDA has issued a Public Health Notification regarding increased risk for electromagnetic interference in any medical telemetry systems operating in the 460-470 MHz frequency bands after December 31, 2005. This interference could compromise patient safety. Learn more »
2002
FDA Public Health Notification: Diathermy Interactions With Implanted Leads and Implanted Systems With Leads (2002) — FDA has received reports in which patients with implanted deep brain stimulators (DBS) died after receiving diathermy therapy. The FDA issued a notification to the doctors about this issue. View the notification (PDF, 92K)
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BIOTRONIK
Performance Report: Visit the BIOTRONIK website to download the latest Product Performance Report (PDF format).
Product Advisory Letter: Visit the Quality and Safety section of the BIOTRONIK website for information. No specific product safety alert website could be found at this time.
Free Pre-paid Explant Return Boxes: BIOTRONIK requires their industry representatives handle all explant returns including mailing the explants back to the manufacturer. Call 1 (800) 284-6689 for further information.
No communication from the Society about a safety alert at this time.
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Boston Scientific (formally known as Guidant)
Performance Report: Visit the Boston Scientific website.
Product Advisory Letter: Visit the Boston Scientific website for the latest advisories.
Free Pre-paid Explant Return Boxes: Visit the website to order a Returned Products Kit — Please contact Technical Services (1.800.CARDIAC or 1.651.582.2698) at any time to report device related performance observations.
2010
Boston Scientific to Immediately Resume Distribution of COGNIS® CRT-Ds and TELIGEN® ICDs in the U.S. (04/15/10) — Boston Scientific Corporation announced that it has received U.S. Food and Drug Administration (FDA) clearance for the two validated manufacturing changes affecting all of its cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs), and that it will immediately resume distribution of its COGNIS® CRT-Ds and TELIGEN® ICDs. The Company is positioned to fully meet customer demand for COGNIS and TELIGEN within 24 hours. Visit the Boston Scientific website to learn more »
Boston Scientific Announces Ship Hold and Inventory Retrieval of ICD and CRT-D Devices (03/15/2010) — Boston Scientific Corporation announced on March 15 that it has stopped shipment and is retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) after determining that some manufacturing process changes were not submitted for approval to the U.S. Food and Drug Administration (FDA). Boston Scientific states that it has no indication that the manufacturing process changes pose any risk to patient safety, and it is not recommending explantation of the devices. Learn more »
2009
Boston Scientific Product Advisory concerning COGNIS CRT-D and TELOGEN ICD (03/24/2009) — Boston Scientific issued a product advisory on March 23, indicating that inappropriate therapy associated with certain right ventricular (RV) lead complications may occur more frequently if the Respiratory Sensor is programmed On. Learn more »
2006
Boston Scientific Announces Physician Communication Related to Products in Its CRM Group (07/2006) — Boston Scientific Corporation announced that it is providing safety information and retrieving a specific subset of pacemakers, cardiac resynchronization pacemakers and implantable cardioverter defibrillators from its sales force and hospital inventories. Learn more »
2005
Public Health Notification: Guidant Ventak Prizm and Contak Renewal ICDs (2005) — The FDA has issued a Public Health Notification for the "Guidant VENTAK PRIZM(r) 2DR and CONTAK RENEWAL(r) and RENEWAL(r) 2 Implantable Cardioverter Defibrillators. It has been classified as a Class I recall. Learn more »
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Medtronic
Performance Report: Visit the Medtronic website.
Product Advisory Letter: Visit theMedtronic's Advisory website to get the latest advisory information.
Free Pre-paid Explant Return Boxes: mailers and guidelines can be requested by contacting the Returned Product Lab:
CRDM Returned Product Analysis Laboratory
Medtronic, Inc.
7000 Central Avenue NE
MS RCE172
Minneapolis, MN 55432-3576 USA
Phone: 1 (800) 328-2518, ext. 44800
e mail: crdm.returnedproduct@medtronic.com
2009
Medtronic, Inc. Releases Patient Safety Information (05/18/09) — Specific subsets of Kappa® and Sigma® series pacemakers may fail at a higher than expected rate due to separation of wires that connect the electronic circuit to other pacemaker components. Learn more »
2009
Sprint Fidelis® Model 6949 Lead Performance (3/13/2009) — "Dear Doctor" letter summarizing the company's most recent review of performance data and Medical Device Reports with Medtronic’s Independent Physician Quality Panel, and the Panel’s updated patient management recommendations. Read letter on the Medtronic website »
2007
Medtronic Suspends Sprint Fidelis Lead Distribution (11/15/2007) — Medtronic suspended distribution of its Sprint Fidelis® defibrillation leads after the death of five patients where a lead fracture may have been a contributing factor. It has been classified as a Class I recall. Learn more »
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Sorin
Performance Report: Visit theSorin website. A link to the latest Performance Report is on the right-hand side.
Product Advisory Letter: Visit the "Our Performance" section of the Sorin’s website for information. No specific product safety alert website could be found at this time.
Free Pre-paid Explant Return Boxes: Sorin requires that their industry representatives handle all explant returns including mailing devices back to the manufacturer. Contact 1 (800) 352-6466 for further information.
No communication from the Society about a safety alert at this time.
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St. Jude Medical
Performance Report: Visit the St. Jude website to download the latest Product Performance Report (PDF format).
Product Advisory Letter: Visit the Communications to Patients section of the St. Jude's website for the latest information. No specific product safety alert website could be found at this time.
Free Pre-paid Explant Return Boxes: Need to order St. Jude Explant Return Boxes? Telephone +1 (800) 681-9293.
No communication from the Society about a safety alert at this time.
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