SustainRecalls & reported problems across all models

We found 4 models of Sustain by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 189 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 3, 2026 — classified as 1 death, 88 injuries, 100 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (50 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Sustain problems

Sustain models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Sustain™ PM2136

  Pulse generator, permanent, implantable
  107 reports
• Sustain™ PM2134

  Pulse generator, permanent, implantable
  1 death43 reports
• Sustain™ PM1136

  Pulse generator, permanent, implantable
  25 reports
• Sustain™ PM1134

  Pulse generator, permanent, implantable
  14 reports

Recent Sustain adverse event reports

The 15 most recent reports across all models, 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 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 ↗
• 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 ↗
• InjuryJan 15, 2026Therapy Delivered to Incorrect Body Area; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER EXPERIENCING INAPPROPRIATE STIMULATION IN THE POCKET AREA. UPON INTERROGATION, THE PACEMAKER WAS FOUND IN BACKUP MODE. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Discomfort

  MAUDE report 24082656 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 22, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED DEVICE EXCHANGE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PULSE GENERATOR HAD ENTERED BACKUP VVI MODE SHORTLY BEFORE BEING REMOVED FROM THE POCKET. THE PULSE GENERATOR WAS EXPLANTED AND REPLACED. THE PATIENT HAD NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22304783 ↗
• 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 ↗

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