Accent™ SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 05414734502740), received between Jun 13, 2018 and Sep 2, 2025 — classified as 8 deaths, 33 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (11 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 88 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. IT WAS NOTED THAT THE PACEMAKER WENT INTO BACKUP VVI MODE. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936146 ↗
• InjuryAug 26, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH HIGH CAPTURE THRESHOLDS NOTED ON THE RIGHT VENTRICULAR LEAD, AND PREMATURE BATTERY DEPLETION NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE LEAD WAS CAPPED, AND THE DEVICE WAS EXPLANTED AND REPLACED. THIS INTERVENTION OCCURRED ON (B)(6) 2025. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900742 ↗
• MalfunctionJul 16, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. UPON DEVICE INTERROGATION, IT WAS NOTED THAT THE PACEMAKER WAS IN BACKUP VVI MODE. THE PACEMAKER WAS RESTORED BACK TO NORMAL. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22527502 ↗
• MalfunctionApr 17, 2025Incorrect Measurement; Unexpected Mode Switch; Incorrect Measurement; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT AT THE CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER EXHIBITED A BACKUP VVI MODE. PROGRAMMING CHANGES WERE MADE. THE RATE ADAPTIVE PACING (RAP) WAS LOWER THAN EXPECTED AFTER RESTORATION. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862624 ↗
• InjuryDec 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH POCKET EROSION AT THE PACEMAKER SITE. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM ¿ PACEMAKER AND RIGHT VENTRICULAR LEAD DUE TO EROSION. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: Pocket Erosion

  MAUDE report 21032109 ↗
• MalfunctionNov 25, 2024Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. THE PACEMAKER EXHIBITED BACKUP VVI OPERATION. THE DEVICE WAS RESET WITH THE HELP FROM TECHNICAL SERVICES. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20769685 ↗
• InjuryJan 24, 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 FOUND THAT THE PACEMAKER WAS IN THE BACK-UP VVI MODE DUE TO ELECTROMAGNETIC FIELD. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18568702 ↗
• MalfunctionNov 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC. UPON INTERROGATION, THE PATIENT'S PACEMAKER EXHIBITED AN INVALID ELECTROGRAMS (ECG) VALUE. THE DEVICE WAS CLEARED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196899 ↗
• MalfunctionNov 9, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT PREVIOUS INTERROGATION SHOWED THE BATTERY LONGEVITY ESTIMATE WAS 4.9 YRS. BUT ON (B)(6) 2023 BATTERY ESTIMATE WAS 6.9 MONTHS WHEN INTERROGATED WITH AN UPDATED SOFTWARE VERSION OF THE PROGRAMMER. THERE WERE ALSO HIGH VENTRICULAR RATE EPISODES PRESENT ON THE PACEMAKER THAT SEEMED TO ORIGINATE FROM RAPIDLY CONDUCTED ATRIAL FIBRILLATION. THERE WERE NO DEVICE CONCERNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18108075 ↗
• MalfunctionJul 24, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE DEVICE WAS IN BACKUP MODE FOR AN UNKNOWN REASON DURING AN IN CLINIC FOLLOW-UP. AN ATTEMPT TO RESTORE THE DEVICE WAS PERFORMED, HOWEVER, IT WAS UNSUCCESSFUL. NO ADDITIONAL INTERVENTION HAS BEEN PERFORMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379915 ↗
• MalfunctionApr 24, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR A CHECK. UPON REVIEW, THE PACEMAKER EXHIBITED FAILURE TO INTERROGATE. NO INTERVENTION WAS PERFORMED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16793191 ↗
• InjuryMar 10, 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 EMERGENCY ROOM WITH SKIN EROSION AND THAT THE DEVICE WAS VISIBLE FROM THE OPENED INCISION SITE OF THE IMPLANTED DEVICE POCKET. THE PHYSICIAN EXPLANTED THE ENTIRE PACEMAKER SYSTEM TO RESOLVE THE ISSUE. THE PATIENT EXPERIENCED NO CONSEQUENCES.

  Patient problems: Pocket Erosion

  MAUDE report 16519827 ↗
• MalfunctionJan 5, 2023Failure to Disconnect; Failure to Disconnect

  DURING AN ELECTIVE REPLACEMENT PROCEDURE, THE SET SCREW WAS UNABLE TO BE UNSCREWED. FORCE WAS NEEDED TO RELEASE THE RIGHT VENTRICULAR LEAD FROM THE DEVICE HEADER. A NEW DEVICE WAS IMPLANTED. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16104307 ↗
• MalfunctionDec 15, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER EXHIBITED NOISE OVER-SENSING DURING ISOMETRICS. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15984678 ↗
• MalfunctionNov 17, 2022No Pacing; No Pacing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED IMPLANT PROCEDURE. DURING THE PROCEDURE, THE PACEMAKER WAS FOUND TO HAVE NO PACING OUTPUT. THE PACEMAKER WAS THEN REMOVED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15821858 ↗
• InjuryOct 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 INFECTION AND SKIN EROSION DURING FOLLOW-UP IN CLINIC. THE IMPLANTED DEVICE POCKET WAS NOTED TO BE HAVING DISCHARGE. THE PHYSICIAN EXPLANTED THE SYSTEM ¿ PACEMAKER AND LEAD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 15672837 ↗
• MalfunctionAug 18, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT SOME UNDERSENSING OCCURRING DUE TO THE SIZE OF THE P WAVES BEING SMALLER THAN WHAT THE DEVICE WAS PROGRAMMED TO WAS OBSERVED. PROGRAMING CHANGES WERE RECOMMENDED. ON 10 AUG 2022, THE PATIENT PRESENTED FOR FOLLOW-UP, DEVICE WAS TESTED AND WAS FINE AND, NO ISSUES WERE NOTED ON THE LEAD. THE DEVICE REMAINS IMPLANTED. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15251498 ↗
• MalfunctionAug 3, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED DURING IMPLANT PROCEDURE THAT THE SET SCREW OF THE PACEMAKER COULD NOT BE TIGHTENED. THE PACEMAKER WAS SUCCESSFULLY EXCHANGED. THE PATIENT WAS STABLE AND ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15158027 ↗
• DeathJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14981057 ↗
• InjuryMay 7, 2022Signal Artifact/Noise; Failure to Capture; Signal Artifact/Noise; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE PACEMAKER EXHIBITED NOISE AND FAILED TO CAPTURE AT MAX OUTPUT. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14322256 ↗
• MalfunctionApr 20, 2022Premature Discharge of Battery; Capturing Problem; Premature Discharge of Battery; Capturing Problem

  IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, INADEQUATE CAPTURE AND A DECREASE IN BATTERY LONGEVITY WERE NOTED ON THE DEVICE. THE PHYSICIAN SUSPECTED THE DECREASE IN BATTERY LONGEVITY WAS DUE TO PREMATURE DEPLETION OF THE BATTERY. THE BATTERY VOLTAGE HAS NOT REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) LEVEL AT THIS TIME. 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 14160817 ↗
• MalfunctionMar 18, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO A SCHEDULED PROCEDURE. DURING THE PROCEDURE, THE PACEMAKER'S SET SCREW WOULD NOT TIGHTEN. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS USED. THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13810081 ↗
• MalfunctionMar 2, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW-UP ON (B)(6) 2022. DURING INTERROGATION OF THE PACEMAKER, IT WAS NOTED THAT THERE WAS OVERESTIMATION OF BATTERY LONGEVITY. NO PROGRAMMING CHANGES WERE MADE TO THE PACEMAKER. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13657338 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-02375. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR UNRELATED PROCEDURE. THE PHYSICIAN NOTICED A SMALL AREA OF INFECTION AROUND THE PACEMAKER. THE PACEMAKER AND INACTIVE RIGHT ATRIAL (RA) LEAD WERE EXPLANTED. THE PATIENT WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 13423203 ↗
• MalfunctionDec 22, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. DEVICE INTERROGATION REVEALED BATTERY ESTIMATE. THE HEALTHCARE PROFESSIONAL SUSPECTS THIS WAS OVERESTIMATED. A REMOTE HOME MONITORING SYSTEM WAS ORDERED FOR THE PATIENT. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057946 ↗

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