Implantable Pacemaker Pulse-Generator
FDA adverse event reports and recall history for implantable pacemaker pulse-generator (product code DXY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 57,695
- Deaths
- 1,947
- Injuries
- 31,431
- Malfunctions
- 23,751
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2012-01-11TerminatedPending
Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements.These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false.
- 2012-01-11TerminatedPending
Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements. These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false.
- 2010-04-26TerminatedNonconforming Material/Component
Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects, and treats atrial tachyarrhythmia episodes. It also provides bradycardia pacing and monitoring of ventricular tachycardia (VT) episodes. Manufactured at: Juncos, Puerto Rico, USA. Medtronic, Inc., Minneapolis, MN 55432 USA.
Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. If the software update referenced above is not implemented, there will be a potential risk of loss of device functionality or risk for loss of therapy at or near ERI in a small number of devices. The software will eliminate this issue, fo
- 2009-06-11TerminatedDevice Design
Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker; models SS103, SS106, SS203, and SS303.
One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.
- 2009-06-11TerminatedDevice Design
Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Rate Responsive Pacemaker; models SR353, SSR203, SSR303, and SSR306.
One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.
- 2009-06-11TerminatedDevice Design
Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Pacemaker, models SD203 and SD303.
One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.
- 2009-06-11TerminatedDevice Design
Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Rate Responsive Pacemaker, models DR353, SDR203, SDR303, and SDR306.
One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.
- 2009-06-11TerminatedDevice Design
Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber atrial sensing, ventricular sensing and pacing Pacemaker, model SVDD303.
One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.
- 2009-06-11TerminatedDevice Design
Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker, model SVVI103, for ventricular use only.
One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.
- 2006-12-19TerminatedOther
St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator (ERI) status.
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