FDA Warning Letter to Abbott (St Jude Medical Inc.)
Dear HRS Members,
On April 12th, 2017 the U.S. Food and Drug Administration (FDA) issued notification to Abbott (St Jude Medical Inc.) that they were in violation of 4 codes of federal regulations (CFRs). This notification was part of the enforcement phase of the FDA’s ongoing investigation of issues with Abbott’s (St Jude Medical Inc.) ICD pulse generators and transmitters. This investigation included a Class I recall of several ICD models due to the risk of abrupt premature battery depletion as well as the alleged cybersecurity vulnerability of the At Home Merlin Transmitter. The letter may be viewed on the FDA’s website .
Our priority is patient safety. No new safety concerns were identified in this phase of the investigation. Thus, recommendations to healthcare professionals regarding patient care are not affected by this latest FDA communication. The previous recommendations issued by FDA along with guidance from HRS on October 2016 and January 2017 remain appropriate.
However, we encourage healthcare professionals and patients to report adverse events or product problems to FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Submit reports to FDA through the MedWatcher mobile app , complete the voluntary reporting form online , download the form , or call 1-800-332-1088 to request a reporting form.
Physicians and patients should discuss the best approach to take based on individual need. The Society will continue to communicate with the FDA, monitor this issue and keep members informed as new information becomes available. Educational tools including a webinar are available on the Learning Center .
Michael R. Gold, MD, PhD, FHRS