Safety Alert- Subset of Medtronic Pacemakers
On January 17, Medtronic issued an urgent voluntary recall and distribution suspension affecting a subset of dual-chamber pacemakers distributed worldwide between March 10, 2017 and January 7, 2019, including the brand names:
- AdaptaTM, VersaTM, and SensiaTM (USA)
- ReliaTM, AttestaTM, SpheraTM, and VitatronTM A/E/G/Q series (outside of USA)
No ICD models or other pacemaker models are affected. The physician notification letter can be accessed here:
Pacemakers in the affected subset, when programmed to a dual-chamber mode with atrial sensing (such as DDD(R) and DDI(R) modes), may experience a rare circuit error that causes the pacemaker to inhibit all pacing output until a ventricular sensed event occurs, after which the device reverts to normal functionality. The root cause and potential clinical impact are described in greater detail in the physician notification letter.
Of the 156,957 affected devices sold worldwide (about 11,000 in U.S.), there have been four reported occurrences in two patients where a pause in pacing therapy was clinically documented. No patient deaths or injuries have been reported. Other patients may have been affected silently, as these episodes would not be detected or noted in the logbook of the device. Patients who are more dependent upon ventricular pacing are more likely to be clinically affected by these events, should they occur. Medtronic estimates that an affected pacemaker in a susceptible pacing mode has a 2.8% chance per month of experiencing a pacing pause of 1.5 seconds or longer.
Medtronic reports that it is developing a software update to be installed in affected pacemakers to correct the problem, with an estimated target for submission to regulatory agencies in Summer 2019 and released upon approval.
Patients and clinicians may determine if a specific pacemaker device is affected by looking up the serial number on Medtronic’s Product Performance website . Pacemakers implanted prior to March 10, 2017 are not affected.
Medtronic provides detailed patient management recommendations in the physician notification letter. For a patient whose pacemaker is programmed to a susceptible mode and either has no underlying escape rhythm or is at risk for a symptomatic pause until a ventricular escape beat occurs, programming to a non-susceptible mode (such as VVI(R) or DVI(R), where atrial sensing cannot occur) is recommended until the corrective software update is installed.
Most other patients can continue routine clinical monitoring without reprogramming. Consideration of generator replacement is advised only in the rare patient who is at high risk for clinical events and cannot tolerate pacing in a non-susceptible mode until the software update is available.
Any adverse events or quality problems experienced with the use of this product should be reported to Medtronic and the FDA MedWatch Safety Information and Adverse Event Reporting Program.
Reporting to Medtronic
Healthcare professionals can contact their local Medtronic Representative or Medtronic Technical Services at 1-800-505-4636 if they have any questions.
Patients can call the Medtronic Patient Services at 1-800-551-5544.
Reporting to the FDA MedWatch Safety Information and Adverse Event Reporting Program
• Complete and submit a report online at www.fda.gov/medwatch/report
• Call 1-800-332-1088 to request a reporting form or download from www.fda.gov/MedWatch/getforms . Forms may be mailed or faxed. Follow instructions on form.