Accent™ SR RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 05414734502757), received between Jun 12, 2018 and Apr 23, 2026 — classified as 12 deaths, 37 injuries, 115 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (43 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 164 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. DURING THE FOLLOW-UP, THE PATIENT'S PACEMAKER WENT INTO BACKUP VVI MODE DURING A CYBERSECURITY UPDATE. THE DEVICE WAS SUCCESSFULLY RESTORED TO NOMINAL SETTINGS, AND THE PATIENT DID NOT EXPERIENCE ANY CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971190 ↗
• MalfunctionNov 28, 2025Loose or Intermittent Connection; Failure to Disconnect; Loose or Intermittent Connection; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SET SCREW OF THE PACEMAKER WAS STRIPPED AND RIGHT VENTRICULAR (RV) LEAD COULD NOT BE REMOVED FROM THE PACEMAKER HEADER. THE PHYSICIAN USED ORTHOPEDIC BONE CRUSHER TOOL TO CRUSH THE PACEMAKER AND REMOVED THE RV LEAD. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669337 ↗
• MalfunctionSep 15, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT DURING AN IN-CLINIC FOLLOW-UP, BACK-UP VVI WAS NOTED ON A PATIENT'S PACEMAKER (PM). DEVICE RESTORATION WAS SUCCESSFULLY PERFORMED, AND THE PM REMAINS IMPLANTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23053787 ↗
• MalfunctionAug 12, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A PACEMAKER THAT EXHIBITED UNDER-SENSING. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790499 ↗
• InjuryMay 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE RIGHT VENTRICLE (RV) LEAD AND THE PACEMAKER (PM) HAD UNKNOWN MALFUNCTIONS. BOTH RV LEAD AND PM WERE EXPLANTED AND REPLACED WITH NEW LEAD AND NEW PM. NO PATIENT CONDITION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112338 ↗
• MalfunctionApr 17, 2025Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A SCHEDULED FOLLOW UP. INTERROGATION OF THE PATIENT¿S PACEMAKER REVEALED THE DEVICE WAS IN A BACK UP MODE. THE PACEMAKER WAS REMOTELY RESTORED TO IT'S NORMAL STATE AND THE PATIENT IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855858 ↗
• MalfunctionJan 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Under-Sensing; Incorrect, Inadequate or Imprecise Result or Readings; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR AN UNRELATED PROCEDURE. THE PACEMAKER EXHIBITED UNDER-SENSING AND A VOLTAGE MARKER ANOMALY. NO INTERVENTION WAS PERFORMED AND THE PATIENT IS BEING MONITORED. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21214707 ↗
• InjuryNov 29, 2024Premature Discharge of Battery; Failure to Sense; Low impedance; Capturing Problem; Premature Discharge of Battery; Failure to Sense; Low impedance; Capturing Problem

  IT WAS REPORTED A PATIENT'S PACEMAKER PRESENTED WITH ABNORMAL BATTERY CONSUMPTION. AN EXAMINATION IN CLINIC FOUND THE LOW PACING IMPEDANCE. LOSS OF SENSING, AND HIGH CAPTURE THRESHOLDS. THE PACEMAKER WAS EXPLANTED AND REPLACED ON (B)(6)2024. POST-PROCEDURE THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20811134 ↗
• MalfunctionNov 17, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE PACEMAKER FAILED TO DISPLAY A LONGEVITY ESTIMATE AND INSTEAD EXHIBIT A PRE-IMPLANT ALERT DUE TO THE BATTERY BEING IN A PERIOD OF RELAXATION. NO INTERVENTION WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20702490 ↗
• MalfunctionOct 31, 2024Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER WAS IN BACKUP VVI MODE. PROGRAMMING CHANGES WERE MADE. THE PATIENT CONDITION WAS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20584862 ↗
• InjuryOct 3, 2024Failure to Interrogate; Pacing Problem; Failure to Interrogate; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC WITH A DECLINED VENTRICULAR RATE. IT WAS NOTED THAT THE PACEMAKER HAD NO MAGNET RESPONSE. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 20356981 ↗
• MalfunctionJul 10, 2024Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, THE PACEMAKER WAS FOUND TO BE IN BACKUP MODE DUE TO ELECTROMAGNETIC INTERFERENCE (EMI). PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716091 ↗
• MalfunctionFeb 26, 2024Pacing Problem; Therapy Delivered to Incorrect Body Area; Pacing Problem; Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A REGULAR DEVICE CHANGE OUT. IT WAS REPORTED THAT AFTER INITIAL USE OF CAUTERIZATION IN THE POCKET OF THE DEVICE, PULSING IN THE POCKET WAS OBSERVED. ONCE CAUTERIZATION STOPPED, THE POCKET STIMULATION DISSIPATED. THIS CONTINUED TO OCCUR AS CAUTERIZATION WAS USED TO OPEN THE POCKET. LARGE PULSE DEFLECTIONS WERE NOTED ON ELECTROCARDIOGRAM (EKG) WITH POCKET STIMULATION APPEARING TO INDICATE UNIPOLAR PACING. THE DEVICE WAS INTERROGATED AGAIN OUTSIDE THE POCKET AND SETTINGS WERE CONFIRMED AS AT PRE-OP TO BE IN BIPOLAR CONFIGURATION. AUTO CAPTURE WAS PROGRAMMED OFF AND THE POLARITY SWITCHED TO MONITOR. NO OTHER ISSUES WERE OBSERVED. THE PACEMAKER WAS REPLACED SUCCESSFULLY. THE ISSUE COULD NOT BE REPRODUCED WITH THE REPLACEMENT DEVICE. THE PHYSICIAN COMMENTED ON A POSSIBLE ZENER DIODE FUNCTION IN RELATION TO ELECTROMAGNETIC FUNCTION POST PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Discomfort

  MAUDE report 18784715 ↗
• InjuryFeb 12, 2024Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  IT WAS REPORTED THAT THE PACING DEPENDENT PATIENT PRESENTED FOR ROUTINE IN-CLINIC FOLLOW UP. DURING THE FOLLOW UP THE PULSE GENERATOR WAS UNABLE TO BE INTERROGATED. SUDDEN PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE PATIENT WAS SCHEDULED FOR EXPLANT AND THE DEVICE WAS REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691102 ↗
• MalfunctionJan 31, 2024Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A SCHEDULED FOLLOW-UP. INTERROGATION OF THE PULSE GENERATOR REVEALED THAT THE PULSE GENERATOR WAS IN BACKUP VVI (BVVI) MODE. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18612684 ↗
• MalfunctionJan 17, 2024Failure to Disconnect; Contamination of Device Ingredient or Reagent; Failure to Disconnect; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PACEMAKER WAS UNABLE TO REMOVE THE SETSCREW FROM THE HEADER DUE TO THE FOREIGN MATERIAL WAS NOTED. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18523488 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-93450. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFECTION. THE PACEMAKER AND THE RIGHT VENTRICULAR LEAD WERE EXPLANTED AND WAS REPLACED WITH A LEADLESS PACEMAKER. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 18225292 ↗
• MalfunctionOct 18, 2023Failure to Disconnect; Failure to Disconnect

  RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2023-50053. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR GENERATOR CHANGEOUT PROCEDURE. DURING PROCEDURE, IT WAS FOUND THAT THE PACEMAKER SETSCREW CANNOT BE LOOSENED. THE CHRONIC RIGHT VENTRICULAR (RV) LEAD WAS CUT AND CAPPED, SO THAT THE PACEMAKER COULD BE EXPLANTED AND REPLACED. THE REPLACEMENT RV LEAD EXHIBITED LOW OUT-OF-RANGE PACING IMPEDANCE AFTER PLACEMENT, SO THE REPLACEMENT RV LEAD WAS NOT IMPLANTED AND AN ALTERNATE NEAR AT HAND WAS IMPLANTED INSTEAD ON (B)(6) 2023. THE PACEMAKER WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17955139 ↗
• MalfunctionOct 2, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT PRESENT FOR FOLLOW UP WITH THE PULSE GENERATOR THAT EXHIBITED A BATTERY LONGEVITY OVER-ESTIMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850817 ↗
• MalfunctionJul 17, 2023Communication or Transmission Problem; Data Problem; Communication or Transmission Problem; Data Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. IT WAS NOTED THAT THE PACEMAKER HAD AN ERROR MESSAGE. IT WAS ALSO NOTED THAT THE MERLIN ON DEMAND WAS NOT ABLE TO SEND TRANSMISSION. THE ISSUE WAS RESOLVE BY CLEARING OUT THE CHARACTERS IN THE PATIENTS INFORMATION. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17331040 ↗
• MalfunctionJun 21, 2023Insufficient Device Problem Information; Data Problem; Insufficient Device Problem Information; Data Problem

  NEW INFORMATION RECEIVED NOTED THAT THE ERROR MESSAGE WAS DISCOVERED DURING FOLLOW-UP IN THE CLINIC. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.

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

  MAUDE report 17168289 ↗
• MalfunctionMay 16, 2023Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED DURING GENERATOR EXCHANGE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PHYSICIAN FAILED TO REMOVE SETSCREW AND LEAD FROM THE PACEMAKER. THE HEADER WAS CUT FREE AND THE DEVICE WAS REMOVED. A NEW PACEMAKER WAS IMPLANTED DURING THE SAME PROCEDURE ON (B)(6) 2023. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16940485 ↗
• MalfunctionApr 18, 2023Pacemaker Found in Back-Up Mode; Interrogation Problem; Pacemaker Found in Back-Up Mode; Interrogation Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH THEIR PACEMAKER (PM) IN BACKUP MODE. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THE PATIENT CONDITION WAS STABLE BEFORE, DURING, AND AFTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762006 ↗
• MalfunctionApr 10, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW OF THE TRANSMISSION, IT WAS NOTED THAT THE PACEMAKER EXHIBITED NOISE OVERSENSING. NO INTERVENTION WAS PERFORMED AND THE PATIENT EXPERIENCED NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16706956 ↗
• MalfunctionFeb 2, 2023Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A DEVICE REPLACEMENT PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO REMOVE THE LEAD FROM THE HEADER OF THE PACEMAKER. THE LEAD WAS CUT AND THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16287801 ↗

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