Safety Alert Resource Center

St. Jude Merlin@home Transmitter

On January 9, 2017 the US Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) issued a safety communication regarding a cybersecurity vulnerability of the St. Jude Merlin@home Transmitter.

St. Jude Medical has developed a software patch for the Merlin@home Transmitter to address this specific cybersecurity vulnerability and it has been validated by the FDA and the DHS. The patch, which was made available beginning January 9, 2017, will be applied automatically to the Merlin@home Transmitter. Patients and patient caregivers need to make sure their Merlin@home Transmitter remains plugged in and connected to the Merlin.net network to receive the patch. Practices can verify that an individual Merlin@home Transmitter has been upgraded at www.Merlin.net.

The communications from the FDA and the DHS raise many questions. The Society’s first priority is patient safety. HRS will provide updates to the Society's membership as more information becomes available.

 

Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices

On October 11 2016, the U.S. Food and Drug Administration issued a safety communication alerting health care providers and patients about premature battery depletion in a subset of St. Jude Medical ICD and CRT-D devices. The devices addressed in this communication are the following St. Jude Medical ICD and CRT-D models manufactured before May 2015:

  • Fortify VR
  • Fortify ST VR
  • Fortify Assura VR
  • Fortify Assura ST VR
  • Fortify DR
  • Fortify ST DR
  • Fortify Assura DR
  • Fortify Assura ST DR
  • Unify
  • Unify Quadra
  • Unify Assura
  • Quadra Assura
  • Quadra Assura MP

Look up a device by serial number to determine if it is affected here.

HRS recommends that physicians contact all of their affected patients to reinforce the FDA's recommendations and schedule office visits to discuss the details of the safety communication. Physicians, patients and their care-givers should determine the best course of action based on individuals' medical history, comorbidities, and clinical conditions.

HRS strongly supports the FDA's recommendation to employ remote monitoring to assist in the early detection of premature battery depletion. This is consistent with the recent HRS Expert Consensus Statement on Remote Interrogation and Monitoring for Cardiovascular Electronic Implantable Devices, which includes a Class I recommendation (level of evidence A) for monitoring all patients.

Educational Activities

Webinar - HRS Roundtable: Managing Risk of Premature and Rapid Battery Depletion- Are you aware of the battery depletion issues which led to an FDA safety communication on the St. Jude Medical ICD and CRT-D devices? HRS released a 70 min webinar discussing how to best managed patients affected by the battery depletion issues of the St. Jude Medical ICD and CRT-D devices.  View the webinar

Live Twitter Chat-The Heart Rhythm Society hosted a live webinar and Twitter Chat on October 24, 2016.

Transcript of the Twitter Chat #STJDevice 665.88 kB

Resources

Heart Rhythm Society
HRS Expert Consensus Statement on Remote Interrogation and Monitoring for Cardiovascular Electronic Implantable Devices
Webinar: Remote Interrogation & Monitoring of Cardiovascular Implantable Electronic Devices Remote Monitoring
Remote Monitoring Patient Information Sheet (.pdf download)

Food and Drug Administration
FDA Safety Communication
Report an Adverse Event: MedWatch

St. Jude Medical
Patient Information and FAQ

St Jude- Dear Dr Letter 102016 479.14 kB St Jude Letter Estimated Performance 102016 42.35 kB