Integrity™ ADx XL DRRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05414734006866), received between Jul 13, 2018 and May 6, 2021 — classified as 1 death, 8 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2021Failure to Disconnect; Failure to Disconnect

  DURING DEVICE REPLACEMENT DUE TO NORMAL BATTERY DEPLETION, THE RIGHT VENTRICULAR (RV) LEAD COULD NOT BE REMOVED FROM THE HEADER OF THE DEVICE. THE RV LEAD WAS CAPPED AND REPLACED AND THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES. RELATED MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11786927 ↗
• InjuryApr 7, 2021Adverse 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 FOR A FOLLOW UP. DURING THE VISIT, THE PATIENT COLLAPSED WHILE SEATED FOR THE INTERROGATION. RECORDS SHOWED THAT THE PATIENT'S PACEMAKER HAD REACHED ELECTIVE REPLACEMENT 14 MONTHS PRIOR TO THE CLINIC VISIT AND THE BATTERY WAS FULLY DEPLETED. THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: Syncope/Fainting

  MAUDE report 11631158 ↗
• DeathOct 30, 2020Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  ADDITIONAL INFORMATION RECEIVED INDICATED THE PHYSICIAN BELIEVED THE BATTERY LONGEVITY OF THE DEVICE WAS WITHIN THE EXPECTED RANGE AND THE DEVICE WAS NOT SUSPECTED TO HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING; HOWEVER, THE DEVICE WAS RETURNED FOR ANALYSIS TO ENSURE IT WAS FUNCTIONING PROPERLY DURING THE PATIENT'S PASSING.

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

  MAUDE report 10766972 ↗
• MalfunctionOct 9, 2020Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, THERE WAS NOISE NOTED ON THE VENTRICULAR CHANNEL OF THE DEVICE. HOWEVER, WHEN THE TELEMETRY HEADWEAR WAS REPOSITIONED, IT APPEARED TO RESOLVE THE NOISE ISSUE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10659431 ↗
• MalfunctionAug 6, 2020Difficult to Remove; Difficult to Remove

  DURING DEVICE REPLACEMENT, THERE WAS DIFFICULTY REMOVING THE ATRIAL LEAD FROM THE HEADER OF THE DEVICE. THE ATRIAL LEAD WAS CAPPED AND THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10376731 ↗
• MalfunctionMar 10, 2020Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR EXPLANT PROCEDURE ON (B)(6) 2020. UPON REVIEW, IT WAS REVEALED THAT THE PACEMAKER HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). UPON INTERROGATION, IT WAS REVEALED THAT THE PACEMAKER COULD NOT BE INTERROGATED. IT WAS SUSPECTED THAT THE PACEMAKER WENT TO END OF LIFE (EOL). THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9813280 ↗
• MalfunctionFeb 26, 2020Misconnection; Misconnection

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGE OUT PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR SET SCREW WAS STRIPPED. IT WAS REMOVED WITH A SET SCREW REMOVAL KIT. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9753696 ↗
• MalfunctionJan 30, 2020Misconnection; Misconnection

  IT WAS REPORTED THAT DURING A ROUTINE GENERATOR CHANGE, THE VENTRICULAR SET SCREW WOULD NOT LOOSEN TO ALLOW THE REMOVAL OF THE LEAD. MULTIPLE WRENCHES WERE USED TO ATTEMPT TO REMOVE THE LEAD BY FORCE. WHEN THE GROMMET WAS REMOVED, THE PHYSICIAN NOTED VISUAL DIFFERENCES IN COMPARISON TO THE ATRIAL SETSCREW. IT WAS NECESSARY TO CAP AND REPLACE THE DAMAGED LEAD. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9650585 ↗
• MalfunctionDec 11, 2019Pacing Intermittently; Pacing Intermittently

  IT WAS REPORTED THAT DURING THE REPLACEMENT PROCEDURE, THE PACEMAKER RATE DROPPED TO 30 BEATS PER MINUTE AND THEN INTERMITTENT LOSS OF OUTPUT WAS OBSERVED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS EXCELLENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9453950 ↗
• InjuryAug 6, 2019Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT A FOLLOW-UP IN CLINIC. UPON INTERROGATION, THE PACEMAKER WAS AT ELECTIVE REPLACEMENT INDICATOR AND IN BACKUP VVI MODE. THE PHYSICIAN EXPLANTED THE DEVICE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8867758 ↗
• InjuryAug 5, 2019Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-06088, 2938836-2019-06089. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP, THE DEVICE WAS FOUND TO BE IN BACK UP MODE. THE PATIENT WAS ASYMPTOMATIC. DURING THE PROCEDURE, BOTH THE RA AND RV LEADS WERE FOUND TO HAVE HAD AN INSULATION BREACH AT THE SUTURE SLEEVE SITE. THE LEADS WERE CAPPED AND REPLACED ON (B)(6) 2019. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE BEFORE, DURING, AND POST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8859775 ↗
• MalfunctionJul 23, 2019Misconnection; Misconnection

  IT WAS REPORTED THAT DURING A GENERATOR REPLACEMENT PROCEDURE, THE PHYSICIAN WAS UNABLE TO REMOVE THE SET SCREW FROM A LEAD AND SUSPECTED THE SCREW TO BE MISSING OR 'THREADED'. THE LEAD WAS CUT AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS NOTED TO BE UNHARMED AND THEIR CONDITION REMAINS WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8819897 ↗
• InjuryJun 28, 2019Premature Discharge of Battery; Premature Discharge of Battery

  SUSPECTED PREMATURE BATTERY DEPLETION ON THE DEVICE WAS NOTED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8744394 ↗
• MalfunctionMar 28, 2019Misconnection; Misconnection

  IT WAS REPORTED THAT THE PATIENT PRESENTED ON (B)(6) 2019 FOR A DEVICE GENERATOR CHANGE PROCEDURE. DURING THE PROCEDURE, THE SET SCREW COULD NOT BE RETRACTED WITH HEX WRENCH AND THE PHYSICIAN HAD DIFFICULTY UNSCREWING THE LEAD FROM THE PULSE GENERATOR. ONCE THE LEADS WERE REMOVED FROM THE DEVICE HEADER, THE DEVICE WAS REPLACED SUCCESSFULLY. THE PATIENT WAS ASYMPTOMATIC AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8462535 ↗
• InjuryDec 6, 2018Failure to Interrogate; Pacemaker Found in Back-Up Mode; Failure to Interrogate; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT A PACER DEPENDENT PATIENT PRESENTED IN CLINIC FOR A ROUTE FOLLOW-UP. IT WAS NOTED THAT THE PULSE GENERATOR WAS IN BACK-UP. IT WAS FURTHER NOTED THAT THE DEVICE COULD NOT BE INTERROGATED. THE PROGRAMMER THEN BECAME UNABLE TO LOCATE THE DEVICE OR REINTERROGATE. IT WAS EVIDENT THAT THE DEVICE WAS STILL PACING. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT'S CONDITION HAS REMAINED STABLE THROUGHOUT THE DURATION OF THE DEVICE CHECK AND REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8139022 ↗
• InjuryDec 3, 2018Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PULSE GENERATOR WAS IN BACKUP VVI MODE. THE DEVICE WAS EXPLANTED. THE PATIENT HAD NO CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8126546 ↗
• InjuryDec 1, 2018Failure to Interrogate; Failure to Interrogate

  DURING A FOLLOW UP, IN WAS NOTED THAT IT WAS NOT POSSIBLE TO INTERROGATE THE DEVICE. THE DEVICE WAS EXPLANTED TO RESOLVE THE EVENT AND THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8122277 ↗
• MalfunctionAug 20, 2018No Device Output; Pacemaker Found in Back-Up Mode; No Device Output; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT HAD PRESENTED FOR A ROUTINE REPLACEMENT PROCEDURE. A DIATHERMY PLASMA BLADE WAS UTILIZED; AN APPARENT AND UNEXPECTED BACKUP MODE OCCURRED PRESUMABLY INDUCED BY THE DIATHERMY. LOSS OF PACING OCCURRED (GENERATOR OUT OF POCKET) FOR SHORT PERIOD. NO LASTING PATIENT SEQUELAE. PROCEDURE COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7799959 ↗
• InjuryJul 16, 2018Failure to Interrogate; Failure to Interrogate

  DURING A FOLLOW-UP, THE DEVICE WAS UNABLE TO BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689646 ↗
• MalfunctionJul 13, 2018Misconnection; Misconnection

  DURING A PROCEDURE, THE SET SCREW WAS UNABLE TO BE LOOSENED FROM THE HEADER. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7685552 ↗

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-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 software
• 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-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