Identity™ 5376Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 05414734006880), received between Jun 12, 2018 and Sep 3, 2025 — classified as 1 death, 13 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Failure to Interrogate” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2025Computer Operating System Problem; Unexpected Mode Switch; Computer Operating System Problem; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR A ROUTINE CHECK-UP. UPON INTERROGATION IT WAS NOTED THAT THE PACEMAKER EXHIBITED BACKUP MODE AND FIRMWARE CORRUPTION DUE TO DEVICE END OF LIFE. AS A RESOLUTION THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22959796 ↗
• MalfunctionMar 13, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR GENERATOR CHANGE. DURING PROCEDURE IT WAS NOTED THAT THE HEX WRENCH WOULD NOT ENGAGE THE SET SCREW ON THE PACEMAKER. A BACKOUT SURGICAL TOOL WAS BROUGHT IN TO REMOVE THE SETSCREWS AND THE PACEMAKER WAS REPLACED SUCCESSFULLY. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18898360 ↗
• InjuryJun 20, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THE RIGHT VENTRICULAR LEAD WAS OVERSENSING NOISE. THE RIGHT VENTRICULAR LEAD WAS REPLACED ON (B)(6) 2023. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17167806 ↗
• MalfunctionMar 14, 2022Difficult to Remove; Failure to Disconnect; Difficult to Remove; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE DEVICE CHANGEOUT. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE LEADS FROM THE OLD DEVICE, THE SCREW DRIVER DID NOT FIT LIKELY DUE TO DAMAGE OR CALCIFICATION AS THE DEVICE HAD BEEN IMPLANTED SINCE 2003. THE PHYSICIAN ENDED UP BREAKING THE DEVICE HEADER IN ORDER TO RELEASE AND CAP THE LEADS. THE PATIENT WAS NOT DEPENDENT ON THE DEVICE. THE POCKET WAS CLOSED. THE PATIENT WAS STABLE CONDITION BEFORE, DURING AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759612 ↗
• InjuryMar 9, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A FOLLOW-UP ON (B)(6) 2022. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER WAS IN BACKUP MODE. ATTEMPTS WERE MADE TO RE-PROGRAM THE DEVICE WHICH WERE UNSUCCESSFUL. THE PHYSICIAN EXPLANTED AND REPLACED THE PACEMAKER ON (B)(6) 2022. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13703282 ↗
• InjuryJan 5, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SYNCOPE. DEVICE INTERROGATION REVEALED OVERSENSING DUE TO NOISE ON THE RIGHT ATRIAL (RA) LEAD. ON (B)(6) 2021, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RA LEAD. THE PATIENT CONDITION WAS STABLE BEFORE, DURING, AND AFTERWARDS.

  Patient problems: Syncope/Fainting

  MAUDE report 13170438 ↗
• MalfunctionNov 30, 2021Failure to Disconnect; Failure to Disconnect

  DURING A DEVICE REPLACEMENT PROCEDURE DUE TO NORMAL ERI, THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS WERE UNABLE TO BE REMOVED FROM THE DEVICE HEADER. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12901256 ↗
• InjuryJul 16, 2021No Pacing; No Pacing

  IT WAS REPORTED THAT PATIENT PRESENTED IN THE EMERGENCY ROOM WITH ASYSTOLE. THE PATIENT'S PACEMAKER HAD REACHED END OF LIFE (EOL) AND WAS UNABLE TO PROVIDE PACING SUPPORT. THE PATIENT WAS RESUSCITATED AND INTUBATED. THE PHYSICIAN ELECTED TO IMPLANT A REPLACEMENT PACEMAKER. THE PATIENT WAS RECOVERING POST PROCEDURE.

  Patient problems: Arrhythmia

  MAUDE report 12181772 ↗
• MalfunctionSep 4, 2020Misconnection; Misconnection

  IT WAS REPORTED THAT PATIENT'S PACEMAKER SETSCREW WAS FOUND TO BE STRIPPED DURING A NORMAL GENERATOR CHANGE OUT. AS A RESULT, THE RIGHT VENTRICULAR LEAD WAS UNABLE TO BE REMOVED FROM THE DEVICE, EVEN WITH THE USE OF MULTIPLE WRENCHES. PHYSICIAN HAD TO RESULT TO DESTROYING THE PACEMAKER HEADER IN ORDER TO CHANGE OUT THE DEVICE. PATIENT WAS STABLE AFTER THE PROCEDURE AND HAD NO SYMPTOMS OR CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10497704 ↗
• MalfunctionJul 1, 2020Break; Failure to Disconnect; Break; Failure to Disconnect

  IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED FOR DEVICE CHANGE OUT PROCEDURE, THE PHYSICIAN WAS NOT ABLE TO REMOVE THE VENTRICULAR LEAD FROM THE DEVICE HEADER. IT WAS FOUND TO BE STUCK AND WAS NOT ABLE TO ME DISCONNECTED. AFTER SEVERAL ATTEMPTS, THE LEAD COULD BE REMOVED BUT THE CLAMPING AREA WAS BROKEN. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10217517 ↗
• InjuryFeb 13, 2020Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT IN CLINIC. DEVICE INTERROGATION REVEALED THAT THE PACEMAKER WAS IN BACKUP VVI. NO INTERVENTION WAS PERFORMED. THE DEVICE WAS AT ERI AND PATIENT WAS REFEREED TO PHYSICIAN FOR DEVICE REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9709001 ↗
• MalfunctionFeb 7, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY IMPEDANCE INCREASED. PREMATURE BATTERY DEPLETION WAS SUSPECTED BUT COULD NOT BE CONFIRMED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9681538 ↗
• InjuryDec 17, 2019Failure to Interrogate; Failure to Interrogate

  DURING AN IN CLINIC FOLLOW-UP, THE DEVICE LOST COMMUNICATION WHILE BEING PROGRAMMED TO ATRIAL AND VENTRICULAR PACING ONLY. ADDITIONAL ATTEMPTS TO INTERROGATE THE DEVICE WERE UNSUCCESSFUL. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9481770 ↗
• InjuryNov 26, 2019Failure to Interrogate; Failure to Interrogate

  NEW INFORMATION RECEIVED NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9376654 ↗
• MalfunctionNov 7, 2019Misconnection; Misconnection

  IT WAS REPORTED THAT DURING GENERATOR CHANGE PROCEDURE, THE SET SCREWS WERE UNABLE TO BE LOOSENED. THE PHYSICIAN REMOVED THE SILICON GROMMETS AND CLEANED THE HEX SLOTS, EVENTUALLY THE RIGHT ATRIAL LEAD COULD BE REMOVED BUT THE RIGHT VENTRICULAR LEAD COULD NOT BE REMOVED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9291182 ↗
• MalfunctionOct 16, 2019Failure to Interrogate; No Pacing; Failure to Interrogate; No Pacing

  NEW INFORMATION NOTES THAT THE PATIENT WAS RECENTLY SEEN BY THE FOLLOWING PHYSICIAN. IT WAS DISCUSSED BY THE PHYSICIAN AND THE PATIENT TO PROBABLY NOT CHANGING THE DEVICE OUT AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9200356 ↗
• MalfunctionAug 19, 2019Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGE DUE TO THE ELECTIVE REPLACEMENT INDICATOR (ERI). DURING INTERROGATION, IT WAS NOTED THAT THE DEVICE WAS IN BACKUP VVI MODE. THE DEVICE WAS BELIEVED TO HAVE REACHED BATTERY DEPLETION ERI WHICH MAY HAVE CONTRIBUTED TO THE BACKUP VVI. THERE WERE NO PATIENT CONSEQUENCES AS A RESULT OF THE BACKUP VVI. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8906628 ↗
• MalfunctionJul 23, 2019Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR ROUTINE FOLLOWUP IN CLINIC. SEVERAL ATTEMPTS WERE MADE TO INTERROGATE THE PACEMAKER, BUT EACH ATTEMPT WAS UNSUCCESSFUL. PATIENT WAS NOT DEVICE DEPENDENT. PACEMAKER EXPLANT PROCEDURE WAS DISCUSSED. PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8818868 ↗
• InjuryJun 9, 2019Failure to Interrogate; Failure to Interrogate

  RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-04599. IT WAS REPORTED AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP, WHEN INTERROGATION FAILED WHILE TESTING WAS BEING PERFORMED, AND THE SESSION ENDED ABRUPTLY. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2019. THE ATRIAL LEAD WAS ALSO CAPPED AND REPLACED ON THE SAME DAY DUE TO LOW IMPEDANCE. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8681419 ↗
• MalfunctionJan 24, 2019Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED DURING A TRANSTELEPHONIC MONITORING (TTM) CHECK, NO RESPONSE WAS OBSERVED AFTER MAGNET WAS PLACED ON DEVICE. THE EXPECTED LONGEVITY WAS CALCULATED FROM LAST CHECK IN OCTOBER AND ESTIMATED APPROXIMATELY FIVE MONTHS TO ELECTIVE REPLACEMENT INDICATOR ASSUMING OUTPUTS AND PACING PERCENTAGE REMAINED THE SAME. PATIENT WAS ASYMPTOMATIC AND WAS SCHEDULED FOR A IN-CLINIC CHECK. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8276743 ↗
• InjuryOct 24, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT A HOSPITAL ON (B)(6) 2018 DUE TO PRECORDIAL PAIN. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL ON (B)(6) 2018 DUE TO HER SYMPTOMS AND HISTORY OF MULTIPLE SURGERIES TO PLACE STENTS. THE PATIENT RECEIVED AN ANGIOPLASTY PROCEDURE ON (B)(6) 2018 UNRELATED TO THE DEVICES. THE NEXT DAY (B)(6) 2018 THE PATIENT HAD A STOKE ADAMS EVENT. A CHEST X-RAY REVEALED THE PACEMAKER WAS BROKEN. THE PATIENT WAS STABLE AND RECEIVED A TEMPORARY PACEMAKER. THE IMPLANTED PACEMAKER WAS DEACTIVATED. THE PATIENT WAS SCHEDULED FOR A PACEMAKER EXPLANT, PROCEDURE DATE (B)(6) 2018. THE PROCEDURE WAS LENGTHY. TESTING OF THE LEADS REVEALED FAILURE TO CAPTURE IN THE RIGHT VENTRICULAR LEAD. THE RIGHT VENTRICULAR LEAD WAS TURNED OFF. THE PHYSICIAN BELIEVES THE PACEMAKER CASE CAME OFF FROM THE BATTERY. THE PACEMAKER WAS REPLACED AND A NEW RIGHT VENTRICULAR LEAD WAS SUCCESSFULLY PLACED IN A DIFFERENT POSITION. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Chest Pain; Complaint, Ill-Defined

  MAUDE report 8001211 ↗
• DeathOct 15, 2018Adverse 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 FOR AN ELECTIVE SYSTEM UPGRADE PROCEDURE AND DECEASED DURING THE SURGERY. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Death

  MAUDE report 7966684 ↗
• InjuryAug 30, 2018Failure to Interrogate; Telemetry Discrepancy; Failure to Interrogate; Telemetry Discrepancy

  IT WAS REPORTED THAT THE PULSE GENERATOR WAS NOT CAPABLE OF INDUCTIVE TELEMETRY AND COULD NOT BE INTERROGATED. IT WAS NOTED THAT THE DEVICE REACHED ERI SEVERAL DAYS AGO. DEVICE REPLACEMENT WAS DISCUSSED. NO INTERVENTION WAS REPORTED. PATIENT WAS DOING WELL AND DID NOT HAVE ANY SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7835834 ↗
• InjuryAug 22, 2018Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT WHEN THE ASYMPTOMATIC PATIENT PRESENTED IN THE HOSPITAL PRIOR TO A SCHEDULED CHANGE-OUT, THE DEVICE WAS FOUND TO BE IN BACKUP VVI. A DEVICE DOWNLOAD WAS UNABLE TO BE PERFORMED DUE TO A LOW BATTERY STATUS. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7806538 ↗
• MalfunctionJun 19, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING DEVICE CHANGE-OUT PROCEDURE, ATRIAL SET SCREW WAS STUCK IN THE HEADER AND ATRIAL LEAD COULD NOT BE REMOVED. FURTHER INVESTIGATION REVEALED A PIECE OF GROMMET WHICH WAS SLIGHTLY OBSCURING THE SET SCREW HOLE. DEVICE WAS EXPLANTED AND REPLACED. PATIENT¿S CONDITION WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7617574 ↗

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-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-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