ANTHEM™ PM3210Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 05414734503785), received between Jun 25, 2018 and Jan 16, 2025 — classified as 5 deaths, 31 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (11 reports).

5 other recalls cover devices cleared under the same FDA submission (P030035); 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2025Data Problem; Interrogation Problem; Data Problem; Interrogation Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A DEVICE CHECK. UPON INTERROGATION, THE PACEMAKER EXHIBITED ERROR MESSAGE DUE TO PLACEMENT OF MAGNET IN THE INDUCTIVE WAND. THE MAGNET WAS REMOVED AND THE ERROR MESSAGE RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21175585 ↗
• MalfunctionMay 31, 2023Pacemaker Found in Back-Up Mode; Therapy Delivered to Incorrect Body Area; Inappropriate or Unexpected Reset; Pacemaker Found in Back-Up Mode; Therapy Delivered to Incorrect Body Area; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO IN CLINIC FOLLOW UP WITH DIAPHRAGM STIMULATION. THE PACEMAKER WAS FOUND TO BE IN BACKUP MODE AFTER AN ATTEMPTED CYBERSECURITY UPGRADE. THE DEVICE WAS SUCCESSFULLY RESTORED BACK TO NORMAL SETTINGS. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17033130 ↗
• InjuryMay 24, 2023Failure to Interrogate; Interrogation Problem; Failure to Interrogate; Interrogation Problem

  NEW INFORMATION NOTED THE PATIENT INITIALLY PRESENTED PRIOR TO A ROUTINE GENERATOR EXCHANGE. DURING THE DEVICE CHECK, THE PACEMAKER COULD NOT BE INTERROGATED THROUGH INDUCTIVE TELEMETRY. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16997825 ↗
• InjuryFeb 1, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PACEMAKER EXHIBITED OVERSENSING OF WIDE QRS WAVE. NO PROGRAMMING CHANGES WERE MADE. PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16275711 ↗
• InjuryJul 18, 2022Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  DURING FOLLOW-UP, NOISE LEADING TO OVERSENSING AND THE DELIVERY OF INAPPROPRIATE HIGH VOLTAGE THERAPY WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. LEAD DAMAGE WAS SUSPECTED BUT WAS NOT CONFIRMED VISUALLY. THE RV LEAD WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: Discomfort

  MAUDE report 15043591 ↗
• InjuryMay 22, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A FOLLOW-UP ON (B)(6) 2022. REVIEW OF THE TRANSMISSIONS REVEALED A PREMATURE DECLINE IN THE BATTERY LIFE OF THE PACEMAKER. THE PACEMAKER WAS EXPLANTED AND REPLACED ON (B)(6) 2022. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14467591 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED WITH AN ERODING POCKET. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Erosion

  MAUDE report 13676499 ↗
• MalfunctionFeb 14, 2022Pacemaker 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 PATIENT'S PACEMAKER WAS IN BACKUP MODE. THE PACEMAKER WAS SUCCESSFULLY RESET TO NORMAL SETTING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524587 ↗
• MalfunctionJan 26, 2022Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THE PACEMAKER EXHIBITED FAR R OVERSENSING ON THE ATRIAL CHANNEL THAT LED TO MULTIPLE AUTOMATED MODE SWITCH (AMS) EPISODES. PROGRAMMING CHANGES WERE MADE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13360053 ↗
• MalfunctionOct 1, 2021Incorrect Measurement; Incorrect Measurement

  NEW INFORMATION NOTES THE PATIENT WAS STABLE BEFORE DURING AND AFTER THE EXPLANT PROCEDURE FOR THE ELECTIVE REPLACEMENT INDICATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565194 ↗
• MalfunctionSep 24, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT A DEVICE DEPENDENT PATIENT PRESENTED IN HOSPITAL AFTER HAVING A CARDIAC ARREST. UPON DEVICE INTERROGATION, FALSE ERI AND EOS ALERTS WERE NOTED AFTER FOUR EXTERNAL DEFIBRILLATION ATTEMPTS FOR VENTRICULAR FIBRILLATION. THE DEVICE FUNCTION WAS STABLE WITH NORMAL BATTERY VOLTAGE. NO PROGRAMMING CHANGES WERE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12529888 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INITIAL MEDICAL DEVICE REPORT WAS SUBMITTED VIA AN ALTERNATIVE SUMMARY REPORT ON (B)(6) 2017 UNDER AUTHORIZATION NUMBER (B)(4) FOR MANUFACTURER ABBOTT UNDER REGISTRATION NUMBER 2017865.

  Patient problems: Unspecified Infection

  MAUDE report 12528239 ↗
• DeathAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-28993. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-28994. IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS CARDIAC ARREST. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Arrhythmia

  MAUDE report 12368109 ↗
• MalfunctionJul 23, 2021Data Problem; Interrogation Problem; Data Problem; Interrogation Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-26634. IT WAS REPORTED IN A CLINICAL FOLLOW UP THAT THE PACEMAKER EXHIBITED POSSIBLE ELECTROGRAM (EGM) DATA CORRUPTION. DATA RETRIEVAL FROM THE PACEMAKER USING DIFFERENT PROGRAMMERS RESULTED IN PROGRAMMER CRASH AND ERROR MESSAGES. IT WAS ALSO NOTED THAT THE TELEMETRY WAS VERY SLOW. RIGHT VENTRICULAR LEAD NOISE WAS ALSO SUSPECTED BUT NOT CONFIRMED. THE DEVICE AND LEAD WILL CONTINUE TO BE MONITORED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12221813 ↗
• InjuryJun 30, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED WITH PREMATURE BATTERY DEPLETION EXHIBITED BY THEIR PACEMAKER. PACEMAKER WAS EXPLANTED AND REPLACED ON 13 (B)(6) 2021. PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094483 ↗
• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN AT THE SITE. UPON VISUAL INSPECTION OF POCKET, THE PACEMAKER WAS NOTED TO HAVE ERODED TROUGH THE SKIN. THE DEVICE WAS EXPLANTED AND REIMPLANTATION OF A NEW DEVICE OCCURRED AT THE SAME TIME IPSILATERAL SIDE AS THE PATIENT IS PACEMAKER DEPENDENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Erosion

  MAUDE report 12003793 ↗
• InjuryMay 24, 2021Premature Discharge of Battery; Failure to Capture; Premature Discharge of Battery; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM EXPERIENCING CHEST PAIN AND ARRHYTHMIA, THE PATIENT'S HEART RATE WAS AT 40 BEATS PER MINUTE. UPON REVIEW, THE PACEMAKER EXHIBITED VOLTAGE LESS THAN THAT OF THE DEVICE'S END OF LIFE SHOWING PREMATURE BATTERY DEPLETION AND AS A RESULT FAILED TO CAPTURE THE HEART. THE PACEMAKER WAS EXPLANTED AND REPLACED. PATIENT WAS STABLE.

  Patient problems: Arrhythmia; Discomfort

  MAUDE report 11871454 ↗
• InjuryApr 7, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT WAS DEPENDENT ON THE DEVICE FOR NORMAL FUNCTION. IT WAS NOTED THAT AN ANOMALY WAS OBSERVED WHEREBY THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS REACHED IN 2014 BUT BATTERY VOLTAGE WAS NORMAL WITH NORMAL DEVICE FUNCTION. REMOTE TRANSMISSION ON (B)(6) 2021 HAD NOT SHOWN ERI BUT IN PERSON CHECK IN CLINIC ON (B)(6) 2021 SHOWED ERI IN 2014. THE PHYSICIAN OPTED TO CHANGE THE GENERATOR SINCE THE PATIENT WAS DEPENDENT. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11631864 ↗
• InjuryMar 25, 2021Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR REPLACEMENT OF THE PULSE GENERATOR DUE TO HIGH PACING THRESHOLD. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572612 ↗
• InjuryMar 3, 2021Premature Discharge of Battery; Incorrect Measurement; Premature Discharge of Battery; Incorrect Measurement

  NEW INFORMATION RECEIVED NOTED THAT DEVICE WAS EXPLANTED AND REPLACED WITH A COMPETITOR'S DEVICE ON AN UNKNOWN DATE. NO PATIENT CONDITION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408674 ↗
• MalfunctionOct 21, 2020Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED TO A FOLLOW-UP IN-CLINIC WITH NOISE OVER-SENSING CAUSING INAPPROPRIATE AUTOMATIC MODE SWITCH EPISODES FROM THEIR PACEMAKER. NOISE WAS ABLE TO BE REPRODUCED DURING ISOMETRIC EXERCISES. PACEMAKER MEDIATED TACHYCARDIA WAS ALSO NOTED. NO INTERVENTION WAS PERFORMED AND PATIENT WAS STABLE AFTER THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10715036 ↗
• InjuryOct 7, 2020Premature Discharge of Battery; Charging Problem; Premature Discharge of Battery; Charging Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR REMOTE FOLLOW UP VIA MERLIN.NET WITH THE PULSE GENERATOR EXHIBITING EXCESSIVE BATTERY DEPLETION AND HIGH CURRENT DRAIN. IT WAS NOTED THAT THE DEVICE HAD STABLE OUTPUTS, PACING LEAD IMPEDANCE TRENDS, AND THERE WERE NO CHANGES IN PACING PERCENTAGE. THE PATIENT COMPLAINED OF INTERMITTENT DIZZINESS AND PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE DEVICE. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: Dizziness

  MAUDE report 10643901 ↗
• InjurySep 24, 2020Adverse 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 THE POCKET EROSION AT THE IMPLANT SITE OF THE PULSE GENERATOR. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE DURING AND POST PROCEDURE.

  Patient problems: Pocket Erosion

  MAUDE report 10583954 ↗
• InjuryJul 28, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON REVIEW, IT WAS DISCOVERED THAT NOISE AND INHIBITION WERE NOTICED ON THE RIGHT AND LEFT VENTRICULAR LEADS. POCKET MANIPULATION WAS PERFORMED AND COULD NOT BE RECREATED. THE LEADS WERE THEN EXAMINED UNDER FLUOROSCOPY AND THERE WERE NO VISIBLE ISSUES. THE PACEMAKER WAS EXPLANTED AND REPLACED, AND NO NOISE WAS OBSERVED THROUGH THE ANALYZER OR REPLACEMENT DEVICE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10333837 ↗
• InjuryJun 30, 2020Failure to Interrogate; Wireless Communication Problem; Failure to Interrogate; Wireless Communication Problem

  NEW INFORMATION RECEIVED NOTES THAT THE DEVICE WAS EXPLANTED AND REPLACED. ELECTIVE REPLACEMENT INDICATOR (ERI) WAS ALSO NOTED.

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 10211387 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030035. 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-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.