SJM CONFIRM™ DM2102Recalls & reported problems
St. Jude Medical, Inc. · Implantable Cardiac Monitor with AF detection · Class 2 · Implant
All models of SJM CONFIRM (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Confirm is an implanted heart rhythm monitor. Its 251 reports often describe the monitor failing to pick up heart signals, being impossible to read with clinic equipment, and batteries running down early, and some led to the monitor being removed. The reports include 42 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 251
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 251 adverse event reports that list this exact device (DI 05414734502573), received between Jun 15, 2018 and Aug 14, 2026 — classified as 42 injuries, 209 malfunctions.
The most frequently reported specific device problem is “Under-Sensing” (63 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, 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.
Reports received per month
Most reported problems
Device problems
- Under-Sensing63
- Failure to Interrogate61
- Inappropriate or Unexpected Reset46
- Data Problem36
- Premature Discharge of Battery21
- Incorrect, Inadequate or Imprecise Result or Readings16
- Adverse Event Without Identified Device or Use Problem12
- Reset Problem6
Patient problems
- No Known Impact Or Consequence To Patient150
- No Clinical Signs, Symptoms or Conditions76
- No Consequences Or Impact To Patient12
- Unspecified Infection7
- Insufficient Information3
- No Information3
- Discomfort2
- Pocket Erosion2
Recent adverse event reports
The 25 most recent of 251 reports, 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 ↗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 ↗InjuryMar 6, 2023Failure to Sense; Failure to Sense
IT WAS REPORTED THE PATIENT PRESENTED FOR FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS DISCOVERED THE INSERTABLE CARDIAC MONITOR (ICM) WAS UNABLE TO SENSE CARDIAC ACTIVITY. THE ICM WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16492101 ↗MalfunctionJan 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
DURING AN IN-CLINIC FOLLOW-UP, AN EGM ANOMALY OCCURRED. ABBOTT TECHNICAL SUPPORT WAS CONTACTED, AND THE DEVICE FIRMWARE WAS REINSTALLED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16225497 ↗InjuryJan 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A DEVICE EXTRACTION NEEDS TO BE PERFORMED GIVEN LACK OF SIGNIFICANT ARRHYTHMIAS AND GIVEN SIGNIFICANT DEVICE SITE DISCOMFORT. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO CONSEQUENCES.
Patient problems: Arrhythmia; Discomfort
MAUDE report 16082985 ↗MalfunctionDec 13, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
NEW INFORMATION RECEIVES NOTES THAT THE ISSUE WAS DISCOVERED DURING THE PATIENT PRESENTED IN THE CLINIC FOR A FOLLOW UP. NO INTERVENTION WAS PERFORMED AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15967318 ↗MalfunctionOct 21, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) WAS FOUND IN BACKUP OPERATION. NO INTERVENTION WAS PERFORMED. THE PATIENT STATUS WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15653973 ↗MalfunctionSep 28, 2022Data Problem; Data Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXHIBITED ERROR MESSAGE. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15499506 ↗MalfunctionAug 31, 2022Failure to Interrogate; Computer Operating System Problem; Failure to Interrogate; Computer Operating System Problem
IT WAS REPORTED THAT UPON INTERROGATION THE IMPLANTABLE CARDIAC MONITOR (ICM) DISPLAYED A MESSAGE NOTING "STORED ELECTROCARDIOGRAM (EGM) IN PROGRESS" WITH NO OTHER INFORMATION. IT WAS NOT POSSIBLE TO NAVIGATE WITH THE USE OF A PROGRAMMER. THERE WAS NO COMPLAINT ON THE PROGRAMMER. THE DEVICE WAS RESTARTED BUT THE ISSUE WAS NOT RESOLVED. A CORRUPT EGM WAS SUSPECTED. A DEVICE FIRMWARE DOWNLOAD AND RESET WAS RECOMMENDED AND TO BE COMPLETED AT A FUTURE VISIT IN CLINIC. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15332221 ↗MalfunctionAug 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
DURING ELECTIVE EXPLANT PROCEDURE, DETACHMENT OF THE HEADER WAS OBSERVED. THE DEVICE WAS EXPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15246604 ↗MalfunctionAug 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
DURING DEVICE EXPLANT DUE TO NORMAL BATTERY DEPLETION, DETACHMENT OF THE DEVICE HEADER WAS OBSERVED. THE EVENT WAS RESOLVED BY EXPLANTING THE DEVICE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15198443 ↗InjuryJul 29, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT PATIENT'S INSERTABLE CARDIAC MONITOR(ICM) WAS IN BACKUP MODE. THE DEVICE WAS EXPLANTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15131402 ↗MalfunctionJul 22, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THE IMPLANTABLE CARDIAC MONITOR (ICM) WAS FOUND IN BACKUP OPERATION. NO INTERVENTION WAS PERFORMED. THE PATIENT STATUS WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15088909 ↗
Other RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION) devices
- Assert-IQ™ DM5500St. Jude Medical, Inc. · Recorder, event, implantable cardiac, (without arrhythmia detection)951 reports
- Assert-IQ™ DM5300St. Jude Medical, Inc. · Recorder, event, implantable cardiac, (without arrhythmia detection)949 reports
- Assert-IQ™ DM5000St. Jude Medical, Inc. · Recorder, event, implantable cardiac, (without arrhythmia detection)226 reports
- SJM CONFIRM™ DM2100St. Jude Medical, Inc. · RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)2 deaths53 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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