Accent™ DRRecalls & reported problems

Summary

The FDA's MAUDE database contains 214 adverse event reports that list this exact device (DI 05414734503600), received between Jun 19, 2018 and Jul 3, 2026 — classified as 20 deaths, 86 injuries, 108 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (29 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 214 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2026Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. REMOTE CARE TECHNICAL SERVICES WAS CONTACTED TO ASSIST WITH A MERLIN ON DEMAND (MOD) TRANSMISSION. THE MOD TRANSMISSION WAS SENT SUCCESSFULLY BUT IT WAS NOTED THAT THE PACEMAKER EXHIBITED TELEMETRY LOCKOUT. THE PACEMAKER WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THE PATIENT REMAINED STABLE BEFORE, DURING AND AFTER PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25701961 ↗
• InjuryNov 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SYMPTOMATIC DUE TO PACEMAKER'S AUTO CAPTURE FEATURE. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23677423 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE HOSPITAL FOR A POCKET REVISION. THE PATIENT'S PACEMAKER WAS FOUND ABOUT TO ERODE THROUGH THE SKIN AND THE TISSUE APPEARED ISCHEMIC LIKELY FROM THE PRESSURE OF DEVICE POSITIONING. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT HAD NO COMPLICATIONS AND WAS IN STABLE CONDITION.

  Patient problems: Pocket Erosion

  MAUDE report 22367678 ↗
• MalfunctionJun 13, 2025Premature Discharge of Battery; Failure to Interrogate; Inappropriate or Unexpected Reset; Premature Discharge of Battery; Failure to Interrogate; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR A ROUTINE CHECK-UP. UPON INTERROGATION IT WAS NOTED THAT THE PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION, AND THE RIGHT-ATRIAL (RA) LEAD AND THE RIGHT-VENTRICULAR (RV) BOTH EXHIBITED LOSS OF CAPTURE AND LOW PACING IMPEDANCE. PROGRAMMING CHANGES WERE PERFORMED, BUT BOTH LEADS PACING IMPEDANCES REMAINED UNCHANGED. THEN, THE PACEMAKER SPONTANEOUSLY WENT INTO BACKUP OPERATION AND FAILED TO BE INTERROGATED. NO FURTHER INTERVENTION WAS PERFORMED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207801 ↗
• MalfunctionMar 25, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PACEMAKER EXHIBITED AN UNDERSENSING ISSUE. NO INTERVENTION WAS PERFORMED AND THE PATIENT EXPERIENCED NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21685070 ↗
• DeathFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MFR REPORT NUMBER: 2017865-2025-12285. RELATED MFR REPORT NUMBER: 2017865-2025-12286. IT WAS REPORTED THAT A PATIENT PASSED AWAY. THE CAUSE OF DEATH IS NOT KNOWN. THE PACEMAKER, ATRIAL LEAD, AND RIGHT VENTRICULAR LEAD WERE EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21308619 ↗
• MalfunctionJan 2, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED A PATIENT'S PACEMAKER PRESENTED IN BACKUP VVI MODE. PROGRAMMING CHANGES WERE MADE TO RESTORE NORMAL PARAMETERS. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060211 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH SWELLING DUE TO INFECTION AND EROSION AT THE DEVICE SITE. THE PACEMAKER, RIGHT ATRIAL LEAD AND RIGHT VENTRICULAR LEAD WERE EXPLANTED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 20554737 ↗
• MalfunctionJul 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR DIZZINESS. DEVICE INTERROGATION REVEALED NOISE OVERSENSING ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: Dizziness

  MAUDE report 19801973 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER WAS EXPLANTED ON (B)(6) 2024 AFTER THE PATIENT SYMPTOMS OF SYNCOPE. THE PATIENT'S CONDITION WAS UNKNOWN.

  Patient problems: Syncope/Fainting

  MAUDE report 19395673 ↗
• MalfunctionFeb 23, 2024Data Problem; Data Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED AN ERROR MESSAGE. THE PROGRAMMING CHANGES WAS PERFORMED AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18764977 ↗
• InjuryJan 5, 2024No Pacing; Noise, Audible; No Pacing; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT HAD AN AUDITORY ALERT DEMONSTRATED AND PRESENTED TO THE CLINIC. UPON REVIEW THE PACEMAKER, IT WAS NO ALERT PRESENTED. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE AND WOULD BE FURTHER MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451872 ↗
• InjuryJan 3, 2024Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED, THAT THE PATIENT PRESENTED WITH PRESYNCOPE. THE PACEMAKER WAS IN BACKUP PACING. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Presyncope; Syncope/Fainting

  MAUDE report 18440130 ↗
• MalfunctionDec 27, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM. INTERROGATION OF THE PULSE GENERATOR NOTED THAT THE PULSE GENERATOR WAS IN BACKUP BVVI MODE. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18396542 ↗
• InjuryNov 2, 2023Over-Sensing; Over-Sensing

  RELATED MANUFACTURER REFERENCE NUMBERS: (B)(4). IT WAS REPORTED, THAT THE PATIENT PRESENTED IN CLINIC. FOR RIGHT VENTRICULAR (RV) LEAD REVISION. IT WAS NOTED, THAT THE PACEMAKER AND RV LEAD EXHIBITED NOISE OVER-SENSING. DURING PROCEDURE, IT WAS OBSERVED, THAT THE RV LEAD FURTHER EXHIBITED EXTERNALIZED CONDUCTOR. THE PACEMAKER AND THE RV LEAD WERE EXPLANTED AND REPLACED. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18059149 ↗
• InjuryOct 18, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER WAS EXPLANTED AND REPLACED DUE TO POTENTIAL EARLY BATTERY DEPLETION. THE PATIENT'S STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958742 ↗
• InjuryOct 17, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. TRANSMISSION REVEALED THAT THE PACEMAKER EXHIBITED DIAGNOSTIC ANOMALY. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17947398 ↗
• InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Discomfort

  MAUDE report 17769153 ↗
• InjurySep 7, 2023Over-Sensing; Over-Sensing

  NEW INFORMATION NOTED THAT THE PACEMAKER WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17705828 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE PACEMAKER PUSHING AGAINST THE SKIN WITH IMPENDING NECROSIS. THE DEVICE WAS EXPLANTED FOR NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI), AND A NEW DEVICE WAS IMPLANTED TO A SUB MUSCULAR POCKET. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS.

  Patient problems: Pocket Erosion

  MAUDE report 17651302 ↗
• DeathAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-38920, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-38921. IT WAS REPORTED THE PATIENT DECEASED. 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 WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17591631 ↗
• MalfunctionAug 6, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR GENERATOR CHANGE DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ER). DURING THE PROCEDURE, IT WAS NOTED THAT THE SET SCREW WAS STRIPPED AND CAUSED DIFFICULTY TO REMOVE THE SET SCREW. THE PROCEDURE CONTINUED WITH THE NEW PACEMAKER IMPLANTED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17467448 ↗
• MalfunctionJun 21, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PACEMAKER EXHIBITED AN OVERSENSING ISSUE. NO INTERVENTION WAS PERFORMED AND THE PATIENT'S CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17169498 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 2017865-2023-23643. RELATED MANUFACTURER REPORT NUMBER: 2017865-2023-23644. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH ERODED POCKET WITH INFECTION AND FEVER. THE PATIENT'S PACEMAKER, ATRIAL LEAD AND RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED. A REPLACEMENT LEADLESS PACEMAKER WAS IMPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Discomfort; Pocket Erosion; Unspecified Infection

  MAUDE report 17163563 ↗
• InjuryJun 5, 2023Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET TRANSMISSION. ANALYSIS OF THE TRANSMISSION NOTED THAT THE PACEMAKER EXHIBITED FAR R OVERSENSING THAT CAUSED INAPPROPRIATE MODE SWITCH. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT STATUS THROUGHOUT THE PROCEDURE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067118 ↗

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-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-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-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