Identity™ 5286Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 05414734006828), received between Jun 13, 2018 and Feb 20, 2025 — classified as 29 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Data Problem; Data Problem

  DURING AN IN CLINIC FOLLOW UP, THE DEVICE WAS INTERROGATED, AND INVALID CHARACTERS RESULTED IN A DEVICE ERROR. TECHNICAL SUPPORT WAS CONTACTED AND A PROGRAMMER INTERROGATION WOULD CLEAR THE DATA CORRUPTION. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426549 ↗
• InjuryJan 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INSPECTION, IT WAS NOTED THAT THE PATIENT HAD POCKET INFECTION AND EROSION. THE POCKET WAS RED, SWOLLEN AND HAD DISCHARGE. THE PACEMAKER SYSTEM WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 18461478 ↗
• InjurySep 28, 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 A RED ULCERATED PACEMAKER POCKET. IT WAS DETERMINED THAT THE PATIENT HAD DEVELOPED INFECTION. THE WHOLE SYSTEM, INCLUDING THE PACEMAKER, WAS EXPLANTED. ANTIBIOTICS WAS ADMINISTERED AND DEBRIDEMENT WAS PERFORMED. PATIENT CONDITION WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 17831267 ↗
• InjuryJun 21, 2023Premature Discharge of Battery; Failure to Interrogate; Battery Problem; Premature Discharge of Battery; Failure to Interrogate; Battery Problem

  IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. PREMATURE BATTERY DEPLETION WAS SUSPECTED. 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 17173904 ↗
• InjuryApr 11, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE IN BACKUP MODE WHEN PATIENT PRESENTED TO THE HOSPITAL. THE PATIENT EXPERIENCED SYNCOPE. NO KNOWN INTERVENTION WAS DONE. THE PATIENT¿S CONDITION WAS STABLE.

  Patient problems: Syncope/Fainting

  MAUDE report 16714056 ↗
• InjuryJan 15, 2023Pacemaker Found in Back-Up Mode; Environmental Compatibility Problem; Pacemaker Found in Back-Up Mode; Environmental Compatibility Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED DURING FOLLOW-UP IN CLINIC. IT WAS NOTED THAT THE PATIENT¿S PACEMAKER WAS IN BACKUP VVI MODE DUE TO MAGNETIC RESONANCE IMAGING (MRI). THE DEVICE WAS FOUND USED IN AN OFF-LABEL MRI ENVIRONMENT. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE IN CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16172316 ↗
• InjuryOct 14, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED PREMATURE BATTERY DEPLETION ON THE PACEMAKER. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE PACEMAKER. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611839 ↗
• InjuryAug 12, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT PATIENT'S PACEMAKER WAS IN BACKUP MODE. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15220405 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC DUE TO AN UNSPECIFIED INFECTION. THE ENTIRE PACEMAKER (PM) SYSTEM WAS EXPLANTED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 14102791 ↗
• MalfunctionMar 8, 2022Signal Artifact/Noise; Incorrect Measurement; Interrogation Problem; Signal Artifact/Noise; Incorrect Measurement; Interrogation Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC. THE PATIENT'S PACEMAKER WAS FOUND TO HAVE SLOW INDUCTIVE TELEMETRY, A DIAGNOSTIC ISSUE, AND ELECTROMAGNETIC INTERFERENCE DETECTED BY THE DEVICE. NO INTERVENTION WAS TAKEN. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691086 ↗
• MalfunctionFeb 9, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR A CHECK. UPON REVIEW, THE PACEMAKER EXHIBITED POST PACED T-WAVE OVER-SENSING EPISODES. PROGRAMMING CHANGES WERE MADE ON THE DEVICE. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13492127 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POCKET INFECTION WAS OBSERVED. THE PHYSICIAN SUSPECTED THE INFECTION WAS PROCEDURE RELATED. THE DEVICE SYSTEM WAS EXPLANTED. THE PATIENT WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12041569 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POCKET INFECTION WAS OBSERVED. THE DEVICE SYSTEM WAS EXPLANTED. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 11879919 ↗
• MalfunctionMay 17, 2021Incorrect Measurement; Data Problem; Incorrect Measurement; Data Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2021 FOR A ROUTINE DEVICE FOLLOW UP. UPON INTERROGATION, IT WAS NOTED THAT AN ERROR MESSAGE SUGGESTED THAT DIAGNOSTICS SHOULD BE CLEARED DUE TO AN INVALID DIAGNOSTIC. AFTER CLEARING THE ERROR MESSAGE, IT WAS NOTED THAT ALL DIAGNOSTIC MEASUREMENTS WERE CLEARED AND RESET. NO INTERVENTION WAS REPORTED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11831933 ↗
• InjuryMay 13, 2021Failure to Interrogate; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Interrogate; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW-UP. DURING THE VISIT, THE PATIENT'S PACEMAKER WAS UNABLE TO BE INTERROGATED. THE PATIENT WAS ASYMPTOMATIC. THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821806 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP WITH A POCKET INFECTION AT THE SITE OF THE PULSE GENERATOR. THE DEVICE WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 11739274 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH A PACEMAKER POCKET EROSION AND INFECTION. PHYSICIAN DID NOT BELIEVE THAT THE INFECTION WAS RELATED TO THE SYSTEM. ENTIRE PACEMAKER SYSTEM WAS EXPLANTED ON (B)(6) 2021. PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: Pocket Erosion

  MAUDE report 11675932 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED EXPERIENCING POCKET EROSION AND POCKET INFECTION. THE PACEMAKER SYSTEM WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 11634541 ↗
• MalfunctionApr 4, 2021Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. THE PACEMAKER COULD NOT BE INTERROGATED AFTER SEVERAL ATTEMPTS. DEVICE REPLACEMENT WAS DISCUSSED; NO INTERVENTION WAS REPORTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611953 ↗
• InjuryMar 24, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC. UPON INTERROGATION, IT WAS OBSERVED THE PACEMAKER HAD EVIDENCE OF PREMATURE BATTERY DEPLETION. NO KNOWN INTERVENTION TOOK PLACE TO ADDRESS THIS ISSUE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566343 ↗
• MalfunctionMar 18, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE PATIENT WITH HEART DISEASE PRESENTED FOR A PACEMAKER IMPLANT. DURING THE OPERATION, WHEN THE DOCTOR USED THE PACEMAKER, THERE WAS POOR CONTACT BETWEEN THE END OF PACING LEAD AND THE PACEMAKER. THE DEVICE WAS NOT USED AND REPLACED. THE OPERATION WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516872 ↗
• MalfunctionFeb 11, 2021Over-Sensing; Device Contamination with Body Fluid; Over-Sensing; Device Contamination with Body Fluid

  DURING A ROUTINE DEVICE EXCHANGE, EPISODES OF NOISE WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE ELECTRICAL PARAMETERS OF THE RV LEAD WERE APPROPRIATE WHEN MEASURING WITH THE PACING SYSTEM ANALYZER (PSA). THE PHYSICIAN NOTED BLOOD IN THE HEADER OF THE DEVICE AND SUSPECTED THAT THIS MAY HAVE CAUSED THE NOISE. THE DEVICE WAS SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11315583 ↗
• InjuryDec 30, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW UP. INTERROGATION SHOWED THE PATIENT'S PACEMAKER BATTERY WAS DEPLETED AND THE PHYSICIAN SUSPECTED PREMATURE BATTERY DEPLETION. THE PATIENT WAS ASYMPTOMATIC. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT.

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

  MAUDE report 11097632 ↗
• MalfunctionDec 16, 2020Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN INITIAL IMPLANT PROCEDURE. THE PACEMAKER EXHIBITED FAILING TO CAPTURE UPON LEAD CONNECTION. THE PHYSICIAN REPLACED THE PACEMAKER DURING PROCEDURE TO RESOLVE THE ISSUE. THE PATIENT WAS IN STABLE CONDITION.

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

  MAUDE report 11017624 ↗
• MalfunctionOct 23, 2020Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DURING AN IN-CLINIC FOLLOW UP, THE DEVICE WAS INTERROGATED AND DIAGNOSTICS CONCERNS WERE NOTED ON THE DEVICE AS SOME OF THE DATA WERE MISSING IN THE REPORT. NO INTERVENTION HAS BEEN CONDUCTED AT THIS TIME. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10726380 ↗

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-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 software
• Z-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 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