SJM CONFIRMRecalls & reported problems across all models

We found 2 models of SJM CONFIRM by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 304 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2018 and Aug 14, 2026 — classified as 2 deaths, 51 injuries, 251 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (83 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SJM CONFIRM problems

SJM CONFIRM models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SJM CONFIRM™ DM2102

  RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)
  251 reports
• SJM CONFIRM™ DM2100

  RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)
  2 deaths53 reports

Recent SJM CONFIRM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Premature Discharge of Battery

  It was reported that a patient presented with premature battery depletion noted on the patient's insertable cardiac monitor. The device was explanted and replaced on (b)(6) 2026. No adverse patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256602 ↗
• InjuryNov 18, 2025Failure to Interrogate; Failure to Interrogate

  DURING AN IN-CLINIC FOLLOW-UP, IT WAS NOT POSSIBLE TO INTERROGATE THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23587248 ↗
• MalfunctionSep 11, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  HOLD FOR BM 9/11. DURING AN IN CLINIC FOLLOW UP, THE DEVICE WAS INTERROGATED AND WAS FOUND IN BACK UP VVI MODE. NO INTERVENTION HAS BEEN PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033472 ↗
• InjurySep 11, 2025Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  DURING AN IN CLINIC FOLLOW UP, THE DEVICE WAS UNABLE TO BE INTERROGATED. PREMATURE BATTERY DEPLETION WAS SUSPECTED AS IN FEBRUARY 2025 THE REMAINING LONGEVITY WAS ESTIMATED TO BE 18 MONTHS. THE DEVICE WAS EXPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031565 ↗
• InjuryMar 31, 2025Premature Discharge of Battery; No Apparent Adverse Event; Premature Discharge of Battery; No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE BATTERY HAD DEPLETED ON THE INSERTABLE CARDIAC MONITOR (ICM). NO ADDITIONAL DETAILS WERE PROVIDED. THE ICM WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21728880 ↗
• MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING EXPLANT, THE HEADER OF THE DEVICE WAS DAMAGED AND DETACHED FROM THE DEVICE. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20836797 ↗
• MalfunctionMay 24, 2024Sensing Intermittently; Under-Sensing; Sensing Intermittently; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INTERMITTENT SENSING AND UNDER-SENSING. NO INTERVENTION WAS PERFORMED. PATIENT STATUS WAS NOT KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19390562 ↗
• MalfunctionApr 30, 2024Under-Sensing; Under-Sensing

  DURING AN IN-CLINIC FOLLOW-UP, EPISODES OF UNDERSENSING WERE OBSERVED ON THE DEVICE. THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214249 ↗
• MalfunctionMar 21, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. DEVICE EXPLANT WAS ANTICIPATED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18955677 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DEVICE POCKET PAIN AND DISCOMFORT. THE IMPLANTABLE CARDIAC MONITOR WAS EXPLANTED. THE PACEMAKER POCKET WAS REVISED AND REMAINED IMPLANTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Discomfort

  MAUDE report 18476094 ↗
• DeathDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DECEASED DUE TO AN UNKNOWN CAUSE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307488 ↗
• MalfunctionNov 21, 2023Failure to Interrogate; Data Problem; Failure to Interrogate; Data Problem

  IT WAS REPORTED THAT THE DEVICE SHOWED AN ERROR MESSAGE AND COULD NOT BE INTERROGATED. A DIFFERENT PROGRAMMER WAS USED TO INTERROGATE THE DEVICE. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18188152 ↗
• MalfunctionNov 8, 2023Failure to Interrogate; Incorrect, Inadequate or Imprecise Result or Readings; Under-Sensing; Failure to Interrogate; Incorrect, Inadequate or Imprecise Result or Readings; Under-Sensing

  ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT WAS LATER SEEN IN CLINIC, AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093026 ↗
• MalfunctionAug 7, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON INTERROGATION, IT WAS NOTED THAT THE INSERTABLE CARDIAC MONITOR WAS IN BACKUP MODE. NO CHANGES OR INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477162 ↗
• MalfunctionMay 11, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THE PATIENT PRESENTED POST-IMPLANT PROCEDURE. DURING DEVICE CHECKS, IT WAS DISCOVERED THE INSERTABLE CARDIAC MONITOR (ICM) WAS IN IN BACKUP MODE. THE ICM WAS SUCCESSFULLY RESTORED. THE PATIENT WAS IN STABLE CONDITION BEFORE, DURING, AND AFTER THE INTERROGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913025 ↗

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