Identity™ 5386Recalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 05414734006903), received between Jun 12, 2018 and Sep 10, 2026 — classified as 3 deaths, 65 injuries, 86 malfunctions.

The most frequently reported specific device problem is “Failure to Interrogate” (25 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 154 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Loose or Intermittent Connection; Failure to Disconnect

  It was reported that the patient presented to hospital for a generator change procedure. During the procedure, it was reported that the set screw of the right atrial (RA) lead was stripped resulting in the RA lead unable to remove from the header of the pacemaker. The RA lead was capped and the pacemaker was explanted. The patient was discharged post procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50708042 ↗
• MalfunctionAug 22, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP, THE PACEMAKER WAS UNABLE TO BE INTERROGATED. NO INTERVENTION OR PROCEDURE WAS REPORTED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870554 ↗
• MalfunctionJul 23, 2025Failure to Disconnect; Contamination of Device Ingredient or Reagent; Failure to Disconnect; Contamination of Device Ingredient or Reagent

  DURING AN ELECTIVE REPLACEMENT PROCEDURE, IT WAS NOT POSSIBLE TO REMOVE THE LEAD FROM THE HEADER OF THE DEVICE. THE SUSPECTED CAUSE OF THE EVENT WAS DUE TO A FOREIGN SUBSTANCE IN THE HEADER. THE DEVICE WAS EXPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575957 ↗
• MalfunctionDec 5, 2024Failure to Disconnect; Failure to Disconnect

  DURING A ROUTINE DEVICE EXCHANGE, THE SET SCREW OF THE RIGHT ATRIAL (RA) PORT IN THE HEADER OF THE DEVICE WAS UNABLE TO LOOSEN. THE RA LEAD WAS CUT, AND THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED TO RESOLVE THIS EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858952 ↗
• MalfunctionOct 4, 2024Incorrect Measurement; Incorrect Measurement

  DURING AN IN CLINIC FOLLOW UP, DIAGNOSTIC DATA WAS NOT SHOWN FROM THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND REINTERROGATION OF THE DEVICE WAS RECOMMENDED TO CLEAR THE DIAGNOSTIC DATA. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370064 ↗
• InjuryJun 11, 2024Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH OVER-SENSING RESULTING IN INAPPROPRIATE AUTOMATIC MODE SWITCH. THIS WAS ALLEGED TO BE DUE TO INSULATION BREACH ON THE RIGHT ATRIAL COMPETITOR LEAD. NO INTERVENTION WAS REPORTED, AND THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512735 ↗
• InjuryJun 4, 2024Unexpected Mode Switch; Unexpected Mode Switch

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW OF THE TRANSMISSION, IT WAS NOTED THAT THE PACEMAKER WAS FOUND IN BACKUP MODE. NO INTERVENTION WAS PERFORMED. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19456661 ↗
• MalfunctionJan 15, 2024Loose or Intermittent Connection; Difficult to Remove; Failure to Disconnect; Loose or Intermittent Connection; Difficult to Remove; Failure to Disconnect

  RELATED MFR REPORT NUMBER: 2017865-2024-01126. IT WAS REPORTED THAT DURING A PROCEDURE THAT THE RIGHT VENTRICULAR (RV) LEAD WAS UNABLE TO BE REMOVED FROM THE PACEMAKER (PM) HEADER AND WAS DAMAGED. THE SET SCREW OF THE HEADER WAS STRIPPED AND WAS UNABLE TO BE REMOVED. THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RV LEAD AND EXPLANT AND REPLACE THE PM. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510899 ↗
• InjuryDec 5, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  RELATED MANUFACTURING REFERENCE NUMBER: 2017865-2023-93942 RELATED MANUFACTURING REFERENCE NUMBER: 2017865-2023-93943 IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH CAPTURE THRESHOLD MEASUREMENTS. THE RA LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD AND THE PULSE GENERATOR WERE EXPLANTED AND REPLACED FOR UNKNOWN REASON. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18271843 ↗
• MalfunctionOct 23, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  RELATED MANUFACTURER REPORT NUMBER: 2017865-2023-50404, 2017865-2023-50405, 2017865-2023-50406. DURING A DEVICE REPLACEMENT PROCEDURE FOR NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI), THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE CAPPED AND REPLACED. THE RA LEAD WAS REPLACED DUE TO NOISE OBSERVED AND THE RV LEAD WAS REPLACED DUE TO PROBE PROTRUSION. ADDITIONALLY, IT WAS OBSERVED THAT BLOOD HAD LEAKED INTO THE DEVICE HEADER OF THE OLD DEVICE AND THAT BLOOD WAS OBSERVED IN THE NEW DEVICE HEADER. THE NEW DEVICE WAS EXPLANTED AND REPLACED DURING THE PROCEDURE TO RESOLVE THE EVENT. THE PATIENT WAS STABLE FOLLOWING THE REPLACEMENT OF THE LEADS AND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987866 ↗
• MalfunctionOct 13, 2023Failure to Disconnect; Failure to Disconnect

  RELATED MANUFACTURER REPORT NUMBER: 2017865-2023-48457 IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED GENERATOR CHANGE OUT PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE RIGHT ATRIAL (RA) LEAD HAD FAILED TO BE DISCONNECTED FROM THE HEADER OF THE PACEMAKER. THE PACEMAKER WAS EXPLANTED AND REPLACED, WHILE THE RA LEAD WAS CAPPED DURING THE SAME PROCEDURE ON (B)(6) 2023. THE PATIENT HAD NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17935109 ↗
• MalfunctionOct 4, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT PRESENTED VIA REMOTE TRANSMISSION. UPON REVIEW, THE PACEMAKER TRIGGERED ELECTIVE REPLACEMENT INDICATION (ERI) WHEN THE BATTERY VOLTAGE STILL ABOVE THE EXPECTED LEVEL. NO INTERVENTION WAS REPORTED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17866795 ↗
• MalfunctionSep 5, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING ROUTINE PROCEDURE THAT A SET SCREW COULD NOT TIGHTEN ON THE PACEMAKER. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACED THE PACEMAKER. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17687494 ↗
• MalfunctionJul 18, 2023Failure to Disconnect; Defective Device; Failure to Disconnect; Defective Device

  IT WAS REPORTED THE PATIENT PRESENTED FOR A ROUTINE GENERATOR REPLACEMENT. DURING THE PROCEDURE, THE RIGHT VENTRICULAR SET SCREW ON THE PACEMAKER COULD NOT BE LOOSENED DUE TO A HEADER ANOMALY. THE RIGHT VENTRICULAR LEAD WAS CAPPED AND THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347821 ↗
• MalfunctionJul 6, 2023Difficult to Remove; Difficult to Remove

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT DURING A GENERATOR REPLACEMENT THAT VISUAL EXAMINATION REVEALED INSULATION DAMAGE ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO NOTED THAT THE HEADER SET SCREW WOULD NOT RELEASE FROM THE HEADER 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 17275367 ↗
• InjuryJul 5, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT THE PACEMAKER WAS INAPPROPRIATELY IN BACK-UP OPERATION. DUE TO LOW BATTERY, THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259660 ↗
• InjuryFeb 28, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW UP IN CLINIC. IT WAS NOTED THAT AT THE LAST FOLLOW IN JUNE, 2022 THE REMAINING LONGEVITY ESTIMATE WAS ABOUT 2 YEARS BUT AFTER 8 MONTHS THE PACEMAKER SEEMED TO HAVE REACHED END OF LIFE (EOL). PREMATURE BATTERY DEPLETION WAS SUSPECTED BY THE PHYSICIAN, THOUGH THE DEVICE WAS IMPLANTED FOR 15 YEARS. THE PHYSICIAN WAS CONCERNED MANAGING AND FOLLOWING UP THE PATIENT MAY BE DIFFICULT DUE TO THE CHANGE IN BATTERY LONGEVITY. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457266 ↗
• InjuryFeb 5, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED DURING CLINICAL FOLLOW-UP. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER WAS FOUND IN BACKUP MODE. NO INTERVENTIONS WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Discomfort

  MAUDE report 16302095 ↗
• InjuryJan 30, 2023Signal Artifact/Noise; Break; High impedance; Failure to Sense; Capturing Problem; Signal Artifact/Noise; Break; High impedance; Failure to Sense; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED DURING CLINICAL FOLLOW-UP. UPON INTERROGATION, IT WAS NOTED THAT THE ATRIAL LEAD EXHIBITED FAILURE TO SENSE, HIGH PACING IMPEDANCE, AND HIGH CAPTURE THRESHOLD DUE TO CLAVICULAR CRUSH. THE REPORTED LEAD WAS CAPPED AND REPLACED ON (B)(6) 2023. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269501 ↗
• MalfunctionOct 5, 2022Failure to Disconnect; Failure to Disconnect

  DURING A ROUTINE DEVICE EXCHANGE PROCEDURE, IT WAS NOTED THE ATRIAL LEAD WAS UNABLE TO BE DISCONNECTED FROM THE DEVICE HEADER. IT WAS SUSPECTED THERE WAS AN ISSUE WITH THE DEVICE HEADER, NO ISSUE WAS SUSPECTED WITH THE ATRIAL LEAD. THE ATRIAL LEAD WAS CAPPED AND NOT REPLACED. REPLACEMENT OF THE ATRIAL LEAD IS NOT ANTICIPATED. A NEW DEVICE WAS IMPLANTED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544604 ↗
• MalfunctionSep 29, 2022Difficult to Remove; Difficult to Remove

  DURING DEVICE EXPLANT DUE TO NORMAL BATTERY DEPLETION, IT WAS REPORTED THERE WAS DIFFICULTY DISCONNECTING THE RIGHT VENTRICULAR LEAD AND RIGHT ATRIAL LEADS FROM THE DEVICE HEADER, LEADING TO A PROLONGED PROCEDURE TIME. A DIFFERENT HEX WRENCH WAS USED TO SUCCESSFULLY DISCONNECT THE LEADS AND TO RESOLVE THE EVENT. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503627 ↗
• MalfunctionAug 13, 2022Loose or Intermittent Connection; Difficult to Remove; Loose or Intermittent Connection; Difficult to Remove

  DURING THE DEVICE EXCHANGE, THE SET SCREW WAS STRIPPED AND WAS UNABLE TO BE REMOVED FROM THE HEADER. THE EVENT WAS RESOLVED BY APPLYING MORE FORCE WITH THE SCREWDRIVER TO REMOVE THE SET SCREW. THE PATIENT EXPERIENCED NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15222561 ↗
• MalfunctionJul 21, 2022Loose or Intermittent Connection; Failure to Disconnect; Loose or Intermittent Connection; Failure to Disconnect

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-15816. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PACEMAKER SET SCREW WAS STRIPPED AND FAILURE TO DISCONNECT, AND SUBSEQUENTLY THE RIGHT VENTRICULAR LEAD WAS DAMAGED TO DISCONNECT SCREW FROM THE HEADER. THE LEAD WAS CAPPED AND REPLACED DURING THE PROCEDURE, AND THE PACEMAKER WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE PATIENT WAS STABLE IN CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080839 ↗
• MalfunctionJun 30, 2022Pacemaker Found in Back-Up Mode; Inappropriate or Unexpected Reset; Pacemaker Found in Back-Up Mode; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE SYMPTOMATIC PATIENT PRESENTED WITH PALPITATIONS IN CLINIC DURING FOLLOW-UP WITH BACKUP VVI. IT WAS NOTED THAT THE DEVICE HAD REACH ERI. DOWNLOAD WAS NOT PERFORMED DUE TO A LOW BATTERY STATUS. THE PATIENT HAS NOT DECIDED WHEN TO HAVE THE DEVICE REMOVED, AS PATIENT DOESN'T NEED THE PACEMAKER. IT WAS LATER NOTED THAT THE LEAD WAS FRACTURED WITH HIGH THRESHOLDS AND HIGH IMPEDANCE. DEVICE IS STILL IN BACKUP VVI. NOTHING WILL BE DONE TO THE LEAD AS THE PATIENT IS NOT USING THE PACEMAKER. NO REPLACEMENT HAS BEEN SCHEDULED. PATIENT CONDITION WAS STABLE. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-13669.

  Patient problems: Discomfort

  MAUDE report 14880622 ↗
• MalfunctionJun 13, 2022Loose or Intermittent Connection; Contamination of Device Ingredient or Reagent; Loose or Intermittent Connection; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A DEVICE CHANGE PROCEDURE. DURING THE PROCEDURE, THE PACEMAKER TORQUE WRENCH WOULD NOT FIT AND THE SET SCREW WAS UNABLE TO BE TURNED. A FOREIGN MATERIAL WAS BELIEVED TO BE BLOCKING THE SET SCREW OPENING. THE PACEMAKER WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14682300 ↗

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-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-0052-04 · Jul 31, 2003 · Terminated
  Pulse Generator