Identity® 5480Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05414734006927), received between Aug 31, 2018 and Nov 21, 2022 — classified as 16 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (13 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2022Premature Discharge of Battery; No Apparent Adverse Event; Premature Discharge of Battery; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT PRESENTED ON (B)(6) 2022 WITH THEIR PACEMAKER AT ELECTIVE REPLACEMENT INDICATOR (ERI), AND INDICATION OF PREMATURE BATTERY DEPLETION COULD NOT BE CONFIRMED. THE DEVICE WAS PENDING EXPLANT, BUT NO INTERVENTION WAS REPORTED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834134 ↗
• InjuryOct 7, 2022Premature Discharge of Battery; No Apparent Adverse Event; Premature Discharge of Battery; No Apparent Adverse Event

  IT WAS REPORTED THE PACEMAKER HAD EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15567300 ↗
• InjuryJul 11, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. UPON REVIEW, IT WAS DISCOVERED THAT THE PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14979230 ↗
• InjuryMar 10, 2022Premature Discharge of Battery; Premature Discharge of Battery

  DURING THE PREVIOUS FOLLOW-UP, APPROXIMATELY SEVEN MONTHS AGO, THE BATTERY LONGEVITY SHOWED LESS THAN TWO YEARS UNTIL ELECTIVE REPLACEMENT INDICATOR (ERI). HOWEVER, DURING THE MOST RECENT FOLLOW-UP, THE BATTERY WAS NOW AT ERI. PREMATURE BATTERY DEPLETION WAS SUSPECTED. DEVICE REPLACEMENT IS ANTICIPATED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720075 ↗
• InjurySep 20, 2021Premature Discharge of Battery; Premature Discharge of Battery

  NEW INFORMATION RECEIVED NOTES THAT THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT CONSEQUENCES REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12498090 ↗
• InjuryAug 20, 2021Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. IT WAS DISCOVERED THAT THE PATIENT'S PACEMAKER WAS UNABLE TO BE INTERROGATED BY RADIOFREQUENCY AND INDUCTIVE MEANS. FURTHERMORE, UPON MAGNET INTERROGATION NO PACING RESPONSE WAS OBSERVED LEADING THE PHYSICIAN TO SUSPECT PREMATURE BATTERY DEPLETION. THEREFORE, THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT WAS STABLE POST PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346388 ↗
• InjuryMay 17, 2021Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT'S PRESENTED FOR A FOLLOW UP IN CLINIC. IT WAS NOTED THAT UPON INTERROGATION THE DEVICE WAS IN BACKUP VVI MODE. THE BACKUP VVI RESET MODE WAS FOUND TO BE DUE TO THE DEVICE HAVING REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838085 ↗
• InjuryOct 19, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. INTERROGATION OF DEVICE REVEALED PREMATURE BATTERY DEPLETION ON THE PACEMAKER AS THE DEVICE REACHED ERI WITHIN FIVE YEARS OF IMPLANT. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. PATIENT WAS IN STABLE CONDITION.

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

  MAUDE report 10701985 ↗
• InjuryJul 8, 2020Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED PACEMAKER CHANGE PROCEDURE. UPON EXAMINATION, THE DEVICE WAS UNABLE TO BE INTERROGATED. THE PHYSICIAN DID NOT ALLEGE THAT THERE WAS PREMATURE BATTERY DEPLETION. THE DEVICE WAS THEN EXPLANTED AND REPLACED SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10245603 ↗
• MalfunctionMay 26, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP IN CLINIC. THE PACEMAKER EXHIBITED VENTRICULAR OVERSENSING. THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10089754 ↗
• InjuryMar 23, 2020Premature Discharge of Battery; No Device Output; Premature Discharge of Battery; No Device Output

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020- 03521. IT WAS REPORTED THAT PATIENT PRESENTED TO FOLLOW UP ON (B)(6) 2020 WITH HIS OWN JUNCTIONAL RHYTHM AND EXPERIENCING FATIGUE. UPON INTERROGATION, THE PACEMAKER EXHIBITED NO PACING ON ELECTROGRAMS. THE BATTERY LONGEVITY HAD SIGNIFICANTLY DROPPED SINCE LAST FOLLOW UP ON (B)(6) 2019, PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. ON (B)(6) 2020, DURING THE PROCEDURE, THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCE AND FAILURE TO CAPTURE IN BIPOLAR CONFIGURATION. THE LEAD WAS REPROGRAMMED TO UNIPOLAR CONFIGURATION. PATIENT WAS STABLE DURING AND AFTER THE PROCEDURE.

  Patient problems: Bradycardia; Fatigue

  MAUDE report 9869510 ↗
• InjuryFeb 24, 2020Premature Discharge of Battery; Premature Discharge of Battery

  DURING AN IN CLINIC FOLLOW-UP, THE DEVICE HAD REACHED END OF LIFE (EOL) AND POSSIBLE PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT EXPERIENCED NO ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9747201 ↗
• InjuryFeb 14, 2020Incorrect Measurement; Incorrect Measurement

  DURING AN IN-CLINIC FOLLOW-UP, THE PACEMAKER WAS INTERROGATED AND SHOWN TO HAVE A LONGEVITY OF APPROXIMATELY SIX MONTHS. 10 DAYS FOLLOWING, THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) INDICATING THE BATTERY DEPLETED FASTER THAN EXPECTED ACCORDING TO DISPLAYED LONGEVITY. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9711030 ↗
• MalfunctionFeb 7, 2020Failure to Interrogate; Pacemaker Found in Back-Up Mode; No Pacing; Failure to Interrogate; Pacemaker Found in Back-Up Mode; No Pacing

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE PACEMAKER IN BACKUP. THE DEVICE COULD NOT BE INTERROGATED. IT WAS NOTED THAT THE PATIENT HAD 3 MRI SCANS IN THE PAST WITHOUT CHANGING THE DEVICE MODE. LOSS OF CAPTURE WAS NOTED, AND THE DEVICE WAS AT ERI. THE PATIENT WAS LOST ON FOLLOW-UP SINCE THE IMPLANT IN 2012. REPLACEMENT WAS DISCUSSED. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9682011 ↗
• InjuryJan 21, 2020Premature Discharge of Battery; Premature Discharge of Battery

  DURING A CLINIC FOLLOW UP, A DECREASE IN THE DEVICE BATTERY LONGEVITY WAS OBSERVED AND POSSIBLE PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9613344 ↗
• MalfunctionAug 26, 2019Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PACEMAKER EXHIBITED VENTRICULAR UNDERSENSING. THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS STABLE FOR THESE PROGRAMMING CHANGES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8930421 ↗
• MalfunctionJun 26, 2019Misconnection; Misconnection

  DURING IMPLANT, INABILITY TO LOOSEN SET SCREW WAS NOTED ON THE DEVICE. 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 8735097 ↗
• InjuryMay 21, 2019Premature Discharge of Battery; Premature Elective Replacement Indicator; Sensing Intermittently; Data Problem; Premature Discharge of Battery; Premature Elective Replacement Indicator; Sensing Intermittently; Data Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A REGULAR SCHEDULED APPOINTMENT IN AN INTERMITTENT ATRIAL SENSED, VENTRICULAR PACED, SINUS RHYTHM. UPON INTERROGATION, THE PROGRAMMER INDICATED THE PACEMAKER REACHED ELECTIVE REPLACEMENT INDICATOR. THE DEVICE'S BATTERY VOLTAGE AND BATTERY LONGEVITY BAR INDICATED ABOVE ERI. BASED OFF PREVIOUS LONGEVITY ESTIMATES, PREMATURE BATTERY DEPLETION WAS SUSPECTED. DURING DEVICE TESTING THE PACEMAKER SUFFICIENTLY SENSED EVENTS HOWEVER THE DEVICE STATED ¿NO INTRINSIC WAS AVAILABLE¿. THE PACEMAKER WAS EXPLANTED AND REPLACED ON (B)(6) 2019. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8627853 ↗
• InjuryDec 6, 2018Premature Discharge of Battery; Pacemaker Found in Back-Up Mode; Premature Discharge of Battery; Pacemaker Found in Back-Up Mode

  DURING FOLLOW-UP, THE DEVICE WAS FOUND IN BACK-UP MODE DUE TO LOW BATTERY VOLTAGE. PREMATURE BATTERY DEPLETION WAS SUSPECTED. DEVICE REPLACEMENT WAS ANTICIPATED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8139544 ↗
• InjuryNov 28, 2018Premature Discharge of Battery; Pacemaker Found in Back-Up Mode; Premature Discharge of Battery; Pacemaker Found in Back-Up Mode

  DURING FOLLOW-UP, THE DEVICE WAS FOUND TO BE IN BACKUP MODE. PREMATURE BATTERY DEPLETION WAS ALSO 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 8113114 ↗
• InjuryAug 31, 2018Failure to Interrogate; Pacemaker Found in Back-Up Mode; Failure to Interrogate; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR THE FOLLOW UP. UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION AND THE TELEMETRY CONNECTION COULD NOT BE ESTABLISHED. ON (B)(6) 2018, THE DEVICE WAS EXPLANTED SUCCESSFULLY. THE PATIENT WAS STABLE THROUGHOUT THE WHOLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7840200 ↗

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-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-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-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