Sustain™ PM2134Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 05414734504720), received between Jan 14, 2019 and Jun 22, 2025 — classified as 1 death, 22 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (9 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 43 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionApr 18, 2025Unexpected Mode Switch; Unexpected Mode Switch

  DURING A FOLLOW UP, THE DEVICE WAS FOUND IN BACK UP VVI (BVVI). THE SUSPECTED CAUSE OF THE BVVI WAS DUE TO LOW BATTERY VOLTAGE. THE BVVI WAS NOT ADDRESSED AS THE DEVICE WAS EXPLANTED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867735 ↗
• InjuryApr 17, 2025Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC DUE TO SYMPTOMS OF LOW HEART RATE, DIZZINESS. AND FAINTING. THE PATIENT'S PACEMAKER FAILED TO BE INTERROGATED, AND IT WAS BELIEVED THAT THE BATTERY HAD DEPLETED PREMATURELY. THE PACEMAKER WAS EXPLANTED AND REPLACED. PATIENT WAS STABLE.

  Patient problems: Arrhythmia; Dizziness; Syncope/Fainting

  MAUDE report 21853660 ↗
• InjuryJul 16, 2024Incorrect Measurement; No Pacing; Incorrect Measurement; No Pacing

  IT WAS REPORTED THAT THE PATIENT FAINTED AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL. UPON INTERROGATION, IT WAS FOUND THAT THE PATIENT'S PACEMAKER FAILED TO DELIVER LOW VOLTAGE OUTPUT. IT WAS FURTHER NOTED THAT AN OVERESTIMATION OF BATTERY LONGEVITY WAS PROVIDED BY THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Syncope/Fainting

  MAUDE report 19752214 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2024-37690. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2024-37691. IT WAS REPORTED THAT IN (B)(6) 2022, THE PATIENT FELT ITCHY AND PAIN AT THE PACEMAKER POCKET SITE, BUT NO TREATMENT WAS GIVEN. IN (B)(6) 2022, THE PATIENT CAME TO THE HOSPITAL DUE TO SKIN REDNESS, SWELLING, AND EROSION AT THE POCKET SITE. THE PHYSICIAN DETERMINED A POCKET INFECTION AND PERFORMED A DEVICE SYSTEM EXPLANT. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE.

  Patient problems: Discomfort; Pocket Erosion; Unspecified Infection

  MAUDE report 19040389 ↗
• InjuryMar 7, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE REACHED ITS ELECTIVE REPLACEMENT INDICATOR (ERI) PREMATURELY. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18856201 ↗
• InjuryJan 5, 2024Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW UP VISIT IN THE CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER WAS FOUND IN BACK-UP VVI MODE. PROGRAMMING CHANGES WERE MADE BUT IT WAS UNSUCCESSFUL. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18449832 ↗
• InjuryDec 20, 2023Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED, THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED, NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RV LEAD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370256 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH POCKET SWELLING, PAIN AND FLUID EXUDATION DUE TO INFECTION. IT WAS PREVIOUSLY NOTED THAT THE PATIENT HAD POCKET REDNESS, FLUID LEAKAGE, AND WOUND DEHISCENCE A YEAR AGO. NO INTERVENTION WAS PERFORMED AT THAT TIME. THE PACEMAKER WAS EXPLANTED, AND REPLACEMENT DEVICE WAS IMPLANTED ON (B)(6) 2023. ANTIBIOTICS WAS ALSO ADMINISTERED. PATIENT CONDITION WAS STABLE.

  Patient problems: Discomfort; Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 18315434 ↗
• MalfunctionJul 17, 2023Loose or Intermittent Connection; No Pacing; Loose or Intermittent Connection; No Pacing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. IT WAS NOTED THAT WHEN THE LEAD WAS CONNECTED TO THE THE PACEMAKER, THE SCREW WAS UNABLE TO BE TIGHTENED AND THERE WAS NO OUTPUT. THE PACEMAKER WAS NOT USED AND REPLACED DURING PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17339729 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH A PACEMAKER INFECTION AND THE DEVICE ERODING OUT OF THE SKIN. THE PACEMAKER WAS EXPLANTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 16591143 ↗
• MalfunctionMar 7, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A CORONARY ARTERY BYPASS SURGERY. POST PROCEDURE, IT WAS NOTED THAT THE PACEMAKER WAS IN BACKUP VVI MODE. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE IN CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495032 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT PRESENTED WITH AN INFECTION. THE PACEMAKER WAS EXPLANTED IN A PROCEDURE ON AN UNKNOWN DATE. POST-PROCEDURE THE PATIENT WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 16219700 ↗
• MalfunctionNov 22, 2022No Pacing; No Pacing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SYSTEM IMPLANT PROCEDURE. DURING THE PROCEDURE, THE PACEMAKER EXHIBITED LOSS OF LOW VOLTAGE OUTPUT. THE PACEMAKER WAS NOT USED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15845281 ↗
• MalfunctionNov 17, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A PACEMAKER IMPLANT PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT FEEL THE SET SCREW ON THE PACEMAKER. THE PACEMAKER WAS REPLACED DURING THE PROCEDURE TO RESOLVE THE ISSUE. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15819013 ↗
• MalfunctionJul 26, 2022Difficult to Remove; Difficult to Remove

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-15708 IT WAS REPORTED THAT THE PATIENT PRESENTED FOR EXPLANT PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND HIGH CAPTURE THRESHOLD. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DISCONNECT THE RA LEAD AND WAS UNABLE TO REMOVE THE SET SCREW. THE RA LEAD AND THE PACEMAKER WERE EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15104409 ↗
• MalfunctionMay 24, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR THE FOLLOW UP. INTERROGATION OF THE PATIENT'S PACEMAKER FOUND THAT THE PACEMAKER WAS IN BACK-UP OPERATION. NO PROGRAMMING OR INTERVENTION WAS PERFORMED. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14491323 ↗
• MalfunctionMay 19, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A PACEMAKER IMPLANT PROCEDURE ON (B)(6) 2022. WHILE ATTEMPTING TO IMPLANT THE PACEMAKER, IT WAS NOTED THAT THERE WAS SET SCREW ISSUE. THE SET SCREW COULD NOT BE TIGHTENED AND HAS A LOOSE CONNECTION. AFTER MULTIPLE FAILED ATTEMPTS, THE WHOLE SYSTEM WAS REMOVED WITHOUT FURTHER INCIDENT IN THE SAME PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14442505 ↗
• InjuryMay 5, 2022Premature Discharge of Battery; Premature Discharge of Battery

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND IS AWAITING EXPLANT. FURTHER INFORMATION WAS REQUESTED, BUT NOT YET AVAILABLE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288056 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DISCHARGE DUE TO POCKET INFECTION. THE DEVICE WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 14215298 ↗
• MalfunctionApr 18, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  DURING FOLLOW-UP, THE DEVICE WAS FOUND IN BACKUP MODE FOLLOWING A RESET DUE TO A NON-MASKABLE INTERRUPT. DURING INTERROGATION, THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137190 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-05427, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-05428. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A CHECK UP WITH SIGNS OF INFECTION. UPON EXAMINATION OF THE SYSTEM, IT WAS NOTED THAT THERE WAS INFECTION WHICH WAS DEVELOPED AT THE POCKET INCISION SITE. THE PACEMAKER, THE RIGHT ATRIAL LEAD AND RIGHT VENTRICULAR LEAD WERE EXPLANTED ON (B)(6) 2022. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT.

  Patient problems: Unspecified Infection

  MAUDE report 13766925 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-37388, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-37389. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH POCKET INFECTION. THE ENTIRE SYSTEM INCLUDING THE PULSE GENERATOR AND THE LEADS WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12858536 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED NOTES THAT THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction

  MAUDE report 12554985 ↗
• MalfunctionSep 3, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED A PATIENT PRESENTED FOR AN IMPLANT PROCEDURE ON (B)(6) 2021. DURING THE OPERATION, THE PACEMAKER SCREW COULD NOT BE TIGHTENED SO THE DEVICE WAS EXCHANGED. POST-PROCEDURE THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425188 ↗

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-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 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