Sustain™ PM1136Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05414734504737), received between Jun 11, 2018 and Feb 17, 2026 — classified as 5 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionFeb 17, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT CLINIC FOR A PACEMAKER REPLACEMENT PROCEDURE DUE TO PACING INHIBITION AND LOSS OF OUTPUT. THE PATIENT EXPERIENCED EPISODES OF ASYSTOLE. THE PACEMAKER WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Arrhythmia

  MAUDE report 24373759 ↗
• MalfunctionJul 23, 2025Unexpected Mode Switch; Unexpected Mode Switch

  DURING AN IN-CLINIC FOLLOW-UP, THE DEVICE WAS FOUND IN BACKUP MODE (BVVI). THE SUSPECTED CAUSE OF THE EVENT WAS DUE TO LOW BATTERY VOLTAGE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575539 ↗
• InjuryJan 5, 2024Failure to Interrogate; Pacemaker Found in Back-Up Mode; Unexpected Mode Switch; Failure to Interrogate; Pacemaker Found in Back-Up Mode; Unexpected Mode Switch

  IT WAS REPORTED THAT THE DEVICE WAS IN BACKUP MODE AND UNABLE TO BE INTERROGATED VIA INDUCTIVE TELEMETRY DURING AN IN CLINIC FOLLOW-UP. 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 18457537 ↗
• InjuryDec 15, 2023Failure to Interrogate; Failure to Interrogate

  DURING AN IN CLINIC FOLLOW UP, THE DEVICE WAS UNABLE TO BE INTERROGATED USING INDUCTIVE TELEMETRY. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336069 ↗
• MalfunctionJun 19, 2023Failure to Interrogate; Data Problem; Failure to Interrogate; Data Problem

  IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, THE DEVICE WAS UNABLE TO BE INTERROGATED AND AN ERROR MESSAGE WAS OBSERVED. ABBOTT TECHNICAL SUPPORT WAS CONTACTED, HOWEVER, NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17160014 ↗
• MalfunctionSep 29, 2022Pacemaker Found in Back-Up Mode; Interrogation Problem; Pacemaker Found in Back-Up Mode; Interrogation Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED NO BACKUP VVI (BVVI) OCCURRED. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND CONFIRMED A TELEMETRY ANOMALY OCCURRED IN WHICH THE DEVICE TELEMETRY DURING INTERROGATION. NO REPROGRAMMING WAS NECESSARY AS THE DEVICE WAS SUCCESSFULLY ABLE TO BE INTERROGATED AFTER MULTIPLE INTERROGATION ATTEMPTS. NO FURTHER INTERVENTION WAS PERFORMED AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15502138 ↗
• MalfunctionSep 22, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DURING CLINIC FOLLOW UP, THE DEVICE WAS INTERROGATED AND MISSING EGMS WERE OBSERVED. THE DEVICE WAS RE-INTERROGATED TO RESOLVE THE EVENT AND NORMAL DEVICE FUNCTION WAS OBSERVED. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15467587 ↗
• InjuryMay 26, 2022Premature Discharge of Battery; Failure to Interrogate; Data Problem; No Pacing; Premature Discharge of Battery; Failure to Interrogate; Data Problem; No Pacing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS. AN ERROR MESSAGE WAS DISPLAYED AND THE DEVICE COULD NOT BE INTERROGATED. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND IT WAS SUSPECTED THAT THE DEVICE HAD REACHED END OF SERVICE (EOS). PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

  Patient problems: Dizziness

  MAUDE report 14504521 ↗
• MalfunctionFeb 2, 2022Failure to Interrogate; Failure to Interrogate

  PRIOR TO AN UNRELATED PROCEDURE, THE DEVICE WAS UNABLE TO BE INTERROGATED. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND SUGGESTED TO REMOVE INTERFERING EQUIPMENT FROM THE PATIENTS ROOM TO RESOLVE THE EVENT. THE DEVICE WAS THEN SUCCESSFULLY INTERROGATED AFTER REMOVING THE INTERFERING EQUIPMENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13422747 ↗
• MalfunctionNov 23, 2021No Pacing; No Pacing

  DURING A ROUTINE DEVICE EXCHANGE, THERE WAS A LOSS OF CARDIAC PACING WHILE USING A PLASMA BLADE DIATHERMY WHICH RESULTED IN THE PATIENT EXPERIENCING ASYSTOLE. THE ARRHYTHMIA WAS TERMINATED USING EXTERNAL PACING. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 12862570 ↗
• MalfunctionNov 19, 2021Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PACEMAKER WAS FOUND IN BACK-UP MODE. NO INTERVENTION WAS PERFORMED; THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843984 ↗
• MalfunctionJul 13, 2021Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW UP IN-CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PATIENT'S PACEMAKER WAS FOUND IN BACKUP VVI MODE. THE DEVICE WAS RESORTED SUCCESSFULLY AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160097 ↗
• InjuryMar 24, 2021Premature Discharge of Battery; Premature Discharge of Battery

  DURING AN IN CLINIC FOLLOW-UP, THE DEVICE WAS FOUND TO HAVE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND PREMATURE DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11564277 ↗
• MalfunctionMar 24, 2021Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  DURING A PACEMAKER UPGRADE PROCEDURE, THE PATIENT HAD A RAPID VENTRICULAR TACHYCARDIA EPISODE. THE EPISODE WAS TERMINATED BY EXTERNAL DEFIBRILLATION. FOLLOWING THE EXTERNAL DEFIBRILLATION THE PACEMAKER WAS OBSERVED TO BE IN BACKUP MODE. THE EVENT WAS RESOLVED BY EXPLANTING AND REPLACING THE PACEMAKER DURING THE UPGRADE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Arrhythmia

  MAUDE report 11562431 ↗
• MalfunctionJan 22, 2021Pacemaker Found in Back-Up Mode; Inappropriate or Unexpected Reset; Pacemaker Found in Back-Up Mode; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE DEVICE WAS FOUND IN BACK-UP MODE DUE TO EXTERNAL INTERFERENCE FOLLOWING AN UNRELATED PROCEDURE. TECHNICAL SUPPORT WAS CONTACTED AND SUGGESTED 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 11219088 ↗
• InjuryJun 12, 2020Premature Discharge of Battery; Premature Discharge of Battery

  DURING A FOLLOW-UP IN CLINIC, THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) SOONER THAN EXPECTED. PREMATURE BATTERY DEPLETION WAS ALLEGED. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10148452 ↗
• MalfunctionNov 27, 2019Premature Discharge of Battery; Premature Discharge of Battery

  DURING AN IN CLINIC FOLLOW-UP, IT WAS OBSERVED THAT THE BATTERY LONGEVITY HAD DEPLETION EXPONENTIALLY. THE PHYSICIAN NOTED THAT THE PATIENT'S OUTPUT WAS INCREASED AND WILL CONTACT TECHNICAL SUPPORT TO DETERMINE IF THE PROGRAMMING CHANGES IMPACTED THE BATTERY LONGEVITY. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME AND THE PATIENT WILL CONTINUE TO BE MONITORED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9384817 ↗
• MalfunctionOct 3, 2019Pacing Problem; Pacemaker Found in Back-Up Mode; Pacing Problem; Pacemaker Found in Back-Up Mode

  DURING AN IN-CLINIC FOLLOW-UP, THE DEVICE WAS INTERROGATED AND BACK-UP MODE WAS NOTED ON THE DEVICE. A DEVICE FIRMWARE DOWNLOAD WAS PERFORMED, HOWEVER THE PATIENT THEN BECAME SYMPTOMATIC. THE DEVICE WAS INTERROGATED ONCE AGAIN AND THE DEVICE WAS PACING AT A HIGHER OUTPUT THAN WHAT WAS PROGRAMMED. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS RESTORED TO NORMAL FUNCTION. THE PATIENT WAS STABLE FOLLOWING THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9151944 ↗
• MalfunctionMar 6, 2019Data Problem; Data Problem

  DURING FOLLOW-UP, THE DEVICE WAS INTERROGATED AND THE BATTERY DATA WAS NOT AVAILABLE. TECHNICAL SUPPORT WAS CONTACTED AND SUSPECTED THE DIAGNOSTICS ISSUE WAS DUE TO EXTERNAL INTERFERENCE DURING INTERROGATION. TECHNICAL SUPPORT SUGGESTED TO INTERROGATE THE DEVICE AGAIN WITHOUT EXTERNAL INTERFERENCE CAUSING EQUIPMENT IN THE VICINITY TO RESOLVE THE ISSUE. THE PATIENT WILL BE MONITORED AT FOLLOW-UP AND WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8394774 ↗
• MalfunctionJan 22, 2019Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  DURING A FOLLOW-UP, IT WAS NOTED THAT THE DEVICE WAS IN BACKUP MODE. THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT AND THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8266603 ↗
• MalfunctionDec 21, 2018Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  DURING A PROCEDURE, A CAUTERY KNIFE CAME IN CONTACT TO THE DEVICE AND THE DEVICE WENT INTO BACK-UP VVI MODE. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8189197 ↗
• MalfunctionNov 15, 2018Problem with Software Installation; Wireless Communication Problem; Problem with Software Installation; Wireless Communication Problem

  DURING DEVICE PREPARATION, THE DEVICE WAS INTERROGATED AND A SOFTWARE ANOMALY WAS NOTED. THE DEVICE WAS NOT USED AND NO PATIENT WAS INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8073272 ↗
• MalfunctionSep 19, 2018Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  DURING A FOLLOW-UP IN CLINIC, THE DEVICE WAS NOTED TO BE IN BACKUP MODE. THE EVENT WAS RESOLVED BY TECHNICAL SUPPORT AND THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7889562 ↗
• MalfunctionJul 18, 2018Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. IT WAS NOTED THAT THE PULSE GENERATOR WAS IN BACK-UP. A DAY BEFORE, THE PATIENT PRESENTED IN THE OPERATING ROOM FOR AN UNRELATED PROCEDURE. THE DEVICE WAS FUNCTIONING PRIOR TO THE SURGERY HENCE, IT WAS SUSPECTED THAT CAUTERY USED DURING THE SURGERY MIGHT HAVE CAUSED THE DEVICE RESET. A DEVICE RESTORATION WAS PERFORMED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7701103 ↗
• MalfunctionJun 11, 2018Data Problem; Data Problem

  DURING A FOLLOW-UP IN CLINIC, THERE WAS AN ERROR MESSAGE RECEIVED DURING INTERROGATION DUE TO A DIAGNOSTIC ANOMALY. NO INTERVENTION WAS TAKEN AND THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7589493 ↗

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-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-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 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-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-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-0052-04 · Jul 31, 2003 · Terminated
  Pulse Generator