Safety Alerts

June 21, 2022 — Abbott has identified the potential for programmer software (MerlinTM PCS) and remote monitoring software applications (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers. Pacemaker/battery functionality, therapy delivery, and longevity remain normal and within specifications. Voltage measurements and ERI (elective replacement indicator), which are based on direct voltage measurement, remain accurate. This advisory does not apply to battery estimates for other devices (such as ICDs).

March 23, 2022 - Abbott has detected a software anomaly in the Merlin^TM and Merlin^TM 2 Patient Care System (PCS) programmers that have software versions supporting Gallant^TM, Neutrino^TM NxT, and Entrant^TM devices (Software Models 3330 v25.0.X-v25.3.X and MER3400 v1.1.X – v1.3.X). The issue is specific to using the Decrement Test Method (either voltage or pulse width decrement threshold testing) on the programmer to perform a pacing capture threshold test on a Gallant, Neutrino NxT, or Entrant device.

October 7, 2021 (Update) - On March 15, 2021, Abbott announced a safety notice that some Assurity and Endurity pacemakers manufactured between 2015 and 2018 experienced moisture ingress into the header of the pacemaker pulse generator, causing a small percentage of devices to fail (initially estimated at 0.049% and now roughly at 0.07%).

June 22, 2021 - Medtronic has announced a medical device correction for the LINQ and LINQ II insertable cardiac monitors (ICMs).

June 21, 2021 - Boston Scientific (BSC) recently announced two distinct, unrelated medical device advisories related to certain pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps). This communication summarizes the 2 alerts and BSC recommendations.

May 13, 2021 - The U.S. Food and Drug Administration (FDA) issued a communication on potential interactions between certain cell phones and smart watches.

March 22, 2021 - Earlier this month, BIOTRONIK announced a field safety notice that some ICDs and CRT-Ds are exhibiting premature battery depletion. HRS is working together with BIOTRONIK and the Food and Drug Administration on this communication to ensure our members have the latest, most accurate information.

March 19, 2021 -  Abbott announced a safety notification that some Assurity and Endurity pacemakers manufactured between 2015 and 2018 have experienced moisture ingress into the header of the pacemaker pulse generator causing a percentage of devices to malfunction. HRS is working together with Abbott and the Food and Drug Administration on this communication to ensure our members have the latest, accurate information.

February 8, 2021 - Medtronic has issued a follow-up to its Product Performance Note relating to battery performance for a subset of Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Defibrillators (CRT-Ds). HRS is working together with Medtronic and the Food and Drug Administration on this communication to ensure our members have the latest information.

December 4, 2020 - On December 3, Boston Scientific announced three advisories related to its Emblem S-ICD. They address the potentials for battery depletion, device damage due to electrical shorting, and lead fracture.