Identity® ADx DRRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734006897), received between Jun 29, 2018 and Sep 30, 2020 — classified as 1 death, 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Disconnect” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathSep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Death

  MAUDE report 10607542 ↗
• MalfunctionMay 31, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  DURING FOLLOW-UP, BACKUP VVI WAS NOTED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND IT IS UNKNOWN WHETHER PREMATURE BATTERY DEPLETION OR NORMAL ERI WAS THE CAUSE OF THE BACKUP VVI. THE DEVICE IS AWAITING EXPLANT AND REPLACEMENT TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8660736 ↗
• InjuryFeb 11, 2019Premature Discharge of Battery; Premature Discharge of Battery

  DURING FOLLOW-UP, THE DEVICE LONGEVITY WAS MEASURED AND PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8329096 ↗
• InjuryDec 10, 2018Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC WITH A PACEMAKER THAT COULD NOT BE INTERROGATED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8148666 ↗
• MalfunctionOct 31, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE OPERATING ROOM FOR A ROUTINE DEVICE CHANGE. DURING THE PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR LEAD COULD NOT BE REMOVED FROM THE HEADER. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2018. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8026850 ↗
• MalfunctionJun 29, 2018Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THE ASYMPTOMATIC PATIENT'S PACEMAKER WAS FOUND TO BE IN BACKUP VVI MODE DURING A MONTHLY DEVICE CHECK. THE DEVICE WAS RESTORED TO NORMAL FUNCTIONING BY REPROGRAMMING. THE PATIENT WAS STABLE FOLLOWING REPROGRAMMING AND WOULD CONTINUE TO BE MONITORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7652676 ↗

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-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