Sustain™ PM2136Recalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 05414734504713), received between Jul 26, 2018 and Sep 3, 2026 — classified as 52 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (30 reports).

9 other recalls cover devices cleared under the same FDA submission (P880086); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Difficult to Interrogate; Unexpected Mode Switch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50595914 ↗
• MalfunctionAug 18, 2026Incorrect Measurement

  Following a magnetic resonance imaging (MRI), a false alert for the elective replacement indicator (ERI) was observed on the device. The device was reprogrammed to resolve event. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308280 ↗
• MalfunctionMay 7, 2026Computer Software Problem; Unexpected Mode Switch

  DURING AN IN-CLINIC FOLLOW-UP, THE PATIENT WAS FEELING DISCOMFORT. AFTER INTERROGATION, THE DEVICE WAS FOUND TO BE IN BACK-UP MODE (BVVI) DUE TO BIT FLIP. ADDITIONALLY, DURING INTERROGATION, WHILE IN BVVI, THE MODEL NUMBER WAS SHOWING INCORRECT. THE DEVICE HAD A FIRMWARE UPDATE WHICH RESOLVED THE BVVI AND CORRECTED THE MODEL NUMBER IN THE PROGRAMMER RECORDS EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: Discomfort

  MAUDE report 25111336 ↗
• MalfunctionFeb 13, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. DEVICE EXPLANT WAS ANTICIPATED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335302 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  NEW INFORMATION RECEIVED INDICATED THAT WHEN THE PATIENT PRESENTED TO THE CLINIC WITH AN UNSPECIFIED INFECTION, THE PHYSICIAN NOTED THAT SOME FUNCTIONS OF THE PACEMAKER WERE DISABLED AND THAT THE DEVICE WAS NOT IN A FULLY OPERATIONAL STATE.

  Patient problems: Hematoma; Pocket Erosion; Unspecified Infection

  MAUDE report 24320116 ↗
• InjuryDec 22, 2025Failure to Interrogate; Failure to Interrogate

  DURING AN IN CLINIC FOLLOW UP, THE DEVICE WAS UNABLE TO BE INTERROGATED. IT WAS NOTED, THE PATIENT HAD RECEIVED CANCER RADIATION THERAPY, IT IS UNKNOWN IF THIS WAS THE CAUSE OF IN THE INABILITY TO INTERROGATE THE DEVICE. IT WAS ALSO NOTED; THE PATIENT HAD NOT HAD A DEVICE CHECK IN A LONG TIME. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865242 ↗
• InjuryDec 18, 2025Premature Discharge of Battery; Premature Discharge of Battery

  DURING IN-CLINIC FOLLOW-UP, AN ELECTIVE REPLACEMENT INDICATOR (ERI) ALERT WAS RECEIVED. PREMATURE BATTERY DEPLETION IS SUSPECTED, ALTHOUGH NOT CONFIRMED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23844016 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ULCER ON THE RIGHT CHEST AND THE PACEMAKER WAS EXPOSED. THE PHYSICIAN SUSPECTED THAT THE INFECTION WAS RELATED TO THE PATIENT'S REPEATED PACEMAKER REPLACEMENTS. THE PACEMAKER WAS EXPLANTED DUE TO THE INFECTION. THE NEW PACEMAKER WAS IMPLANTED ON (B)(6) 2025. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 23529064 ↗
• MalfunctionAug 22, 2025Unexpected Mode Switch; Unexpected Mode Switch

  DURING AN IN-CLINIC FOLLOW-UP WHILE ATTEMPTING TO PERFORM A SOFTWARE DOWNLOAD, THE DEVICE WENT INTO BACK-UP VVI (BVVI) MODE. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS RESTORED BY A FIRMWARE DOWNLOAD TO RESOLVE THE EVENT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874239 ↗
• MalfunctionMay 28, 2025Loose or Intermittent Connection; Failure to Disconnect; Loose or Intermittent Connection; Failure to Disconnect

  DURING A ROUTINE DEVICE EXCHANGE PROCEDURE, THE ATRIAL SET SCREW COULD NOT BE LOOSENED AND THE SET SCREW APPEARED TO BE STRIPPED. ADDITIONALLY, THE HEX WRENCH WOULD NOT FIT INTO THE SET SCREW. THE ATRIAL LEAD WAS CUT AND THE DEVICE WAS EXPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102028 ↗
• MalfunctionMay 14, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE DEVICE WAS FOUND IN BACKUP MODE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING, WHICH WAS PERFORMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023388 ↗
• MalfunctionApr 29, 2025Unexpected Mode Switch; Unexpected Mode Switch

  DURING AN IN-CLINIC FOLLOW-UP, THE DEVICE WAS FOUND TO BE IN BACKUP (BVVI). ABBOTT TECHNICAL SUPPORT WAS CONTACTED, A DEVICE FIRMWARE RESET WAS ATTEMPTED, HOWEVER THE RESET WAS NOT SUCCESSFUL, AND A DEVICE REPLACEMENT IS ANTICIPATED. THE PATIENT IS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927293 ↗
• InjuryApr 18, 2025Incorrect Measurement; Incorrect Measurement

  ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866923 ↗
• InjuryMar 13, 2025Failure to Interrogate; Battery Problem; No Pacing; Unexpected Mode Switch; Failure to Interrogate; Battery Problem; No Pacing; Unexpected Mode Switch

  DURING AN IN-CLINIC FOLLOW-UP, THE DEVICE WAS UNABLE TO BE INTERROGATED AND DID NOT ELICIT A MAGNET RESPONSE. UPON INVESTIGATION, THE DEVICE WAS FOUND TO HAVE ENTERED BACKUP VVI (BVVI) MODE, THE DEVICE WAS NO LONGER PROVIDING PACING, AND THE BATTERY IMPEDANCE WAS HIGH. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21594707 ↗
• InjuryJan 20, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT A FALSE ELECTIVE REPLACEMENT INDICATOR (ERI) ALERT WAS OBSERVED ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191504 ↗
• MalfunctionJan 3, 2025Failure to Capture; High impedance; Over-Sensing; No Pacing; Failure to Capture; High impedance; Over-Sensing; No Pacing

  DURING A CLINIC FOLLOW-UP, EPISODES OF OVERSENSING, HIGH PACING IMPEDANCE, LOSS OF LOW-VOLTAGE PACING, AND LOSS OF CAPTURE WERE OBSERVED ON THE DEVICE ON A NON-PACEMAKER DEPENDENT PATIENT. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072208 ↗
• MalfunctionDec 27, 2024Unexpected Mode Switch; Unexpected Mode Switch

  DURING A CLINIC FOLLOW-UP, THE DEVICE WAS OBSERVED TO BE IN BACKUP (BVVI) MODE DUE TO AN UNKNOWN CAUSE. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029022 ↗
• InjuryNov 21, 2024Battery Problem; Unexpected Mode Switch; Battery Problem; Unexpected Mode Switch

  DURING AN IN CLINIC FOLLOW UP, THE DEVICE WAS OBSERVED TO BE IN BACK UP MODE. TECHNICAL SUPPORT WAS CONTACTED AND HIGH BATTERY IMPEDANCE WAS ALSO OBSERVED. TECHNICAL SUPPORT RECOMMENDED DEVICE REPLACEMENT AS THE DEVICE WAS NEARING END OF LIFE. DURING THE DEVICE REPLACEMENT PROCEDURE, A FRACTURE WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. THE DEVICE WAS REPLACED WITH A VR PACEMAKER AND THE RA LEAD WAS CAPPED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751305 ↗
• MalfunctionNov 13, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DIAGNOSTIC INFORMATION WAS NOT AVAILABLE UPON DEVICE INTERROGATION. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING, WHICH WAS ANTICIPATED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678948 ↗
• InjuryJun 10, 2024Premature Discharge of Battery; Over-Sensing; Low impedance; Premature Discharge of Battery; Over-Sensing; Low impedance

  IT WAS REPORTED THAT FAR FIELD P-WAVE OVERSENSING AND AN UNEXPECTED DROP IN REMAINING BATTERY LONGEVITY WAS OBSERVED ON THE DEVICE. DIFFERENT DEVICE PACING MODES WERE TESTED, HOWEVER, THE ISSUES STILL PERSISTED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505822 ↗
• InjuryMay 23, 2024Unexpected Mode Switch; Unexpected Mode Switch

  DURING AN IN-CLINIC FOLLOW-UP, THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE (BVVI). TECHNICAL SUPPORT WAS CONTACTED AND A FIRMWARE DOWNLOAD WAS ATTEMPTED, HOWEVER IT COULD NOT BE COMPLETED. FURTHER INTERVENTION WAS PLANNED, BUT NOT YET PERFORMED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19383309 ↗
• InjuryMar 15, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, ELECTIVE REPLACEMENT INDICATOR (ERI) ALERT WAS NOTED ON THE DEVICE, HOWEVER, THE BATTERY VOLTAGE WAS ABOVE ERI LEVEL. ABBOTT TECHNICAL SUPPORT WAS CONTACTED, THE SESSION RECORDS WERE REVIEWED, AND THE ERI ALERT WAS SUSPECTED TO BE A FALSE ALERT. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913009 ↗
• MalfunctionFeb 14, 2024Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS EXPLANTED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705498 ↗
• InjuryJan 4, 2024Interrogation Problem; Interrogation Problem

  DURING AN IN CLINIC FOLLOW UP, THE DEVICE WAS ATTEMPTED TO BE INTERROGATED HOWEVER THE DEVICE KEPT RESTARTING THE INTERROGATION PROCESS ON ITS OWN, RESULTING IN THE DEVICE BEING UNABLE TO BE INTERROGATED. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED FURTHER INVESTIGATION VIA AN ADDITIONAL IN CLINIC FOLLOW UP. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE BEING MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446362 ↗
• InjuryOct 27, 2023Premature Discharge of Battery; Pacemaker Found in Back-Up Mode; Battery Problem; Premature Discharge of Battery; Pacemaker Found in Back-Up Mode; Battery Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL AFTER EXPERIENCING DIZZINESS AND A FALL AT HOME. UPON INTERROGATION, THE PACEMAKER WAS IN BACKUP VVI MODE AND EXHIBITED PREMATURE BATTERY DEPLETION AND INCREASED BATTERY IMPEDANCE. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Dizziness

  MAUDE report 18026306 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P880086. One submission often covers many models, so check the product and lot details in each record.

• Z-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• Z-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 software
• Z-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 software
• Z-0429-2012 · Sep 23, 2011 · Terminated
  Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0430-2012 · Sep 23, 2011 · Terminated
  Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0296-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510
• Z-0297-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
• Z-0298-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
• Z-0052-04 · Jul 31, 2003 · Terminated
  Pulse Generator