SJM CONFIRM™ DM2100Recalls & reported problems
St. Jude Medical, Inc. · Implantable Cardiac Monitor · Class 2 · Implant
All models of SJM CONFIRM (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Confirm implantable cardiac monitor is a small device placed under the skin to record heart rhythm events over time. Most of the 53 reports describe the monitor missing or under-detecting rhythms, resetting on its own, running out of battery early, or failing to hand over its stored data when a clinic tried to read it, sometimes filling memory so fainting spells went unrecorded. Nine reports describe injuries and 2 describe deaths, with no known device link reported. 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
- 53
- Deaths reported
- 2
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 05414734502597), received between Jun 13, 2018 and Dec 11, 2023 — classified as 2 deaths, 9 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Under-Sensing” (20 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Under-Sensing20
- Failure to Interrogate9
- Inappropriate or Unexpected Reset8
- Premature Discharge of Battery7
- Adverse Event Without Identified Device or Use Problem6
- Data Problem6
- Detachment of Device or Device Component2
- Interrogation Problem2
Patient problems
- No Known Impact Or Consequence To Patient42
- No Clinical Signs, Symptoms or Conditions4
- No Information3
- No Consequences Or Impact To Patient2
- Death1
- No Patient Involvement1
- Pain1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionSep 17, 2021Failure to Interrogate; Inappropriate or Unexpected Reset; Failure to Interrogate; Inappropriate or Unexpected Reset
DURING A CLINIC FOLLOW-UP, THE DEVICE WAS OBSERVED TO BE IN BACK-UP (BVVI) MODE. ADDITIONALLY, WHEN TRYING TO DOWNLOAD THE DEVICE IMAGE, THE DEVICE WAS UNABLE TO BE INTERROGATED. TECHNICAL SUPPORT WAS CONTACTED, BUT NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12487938 ↗MalfunctionMay 27, 2021Failure to Interrogate; Failure to Interrogate
DURING AN IN-CLINIC FOLLOW-UP, THE DEVICE WAS UNABLE TO BE INTERROGATED. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING TO RESOLVE THE EVENT. THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11895032 ↗MalfunctionSep 25, 2020Failure to Interrogate; Inappropriate or Unexpected Reset; Failure to Interrogate; Inappropriate or Unexpected Reset
ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE DEVICE WAS ATTEMPTED TO BE INTERROGATED BUT WAS UNSUCCESSFUL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10587772 ↗InjuryAug 16, 2020Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate
IT WAS REPORTED THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. WHEN INTERROGATION WAS ATTEMPTED ON THE IMPLANTABLE CARDIAC MONITOR, IT WAS UNABLE TO BE PERFORMED. IT WAS SUSPECTED THE DEVICE HAD PREMATURE BATTERY DEPLETION AS THE REASON FOR THE INTERROGATION ISSUES. THE DEVICE WAS EXPLANTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10411973 ↗MalfunctionJul 28, 2020Data Problem; Data Problem
IT WAS REPORTED THAT (B)(6) 2020 ELECTROCARDIOGRAMS (EGMS) SHOWED THE PATIENT'S FAINTING EVENTS WERE NOT RECORDED DUE TO THE DEVICE HAVING REACHED 100% STORAGE (B)(6) 2020. THE RECORDED SESSIONS DISPLAYED "CONTINUOUS SCROLLING" OR WERE "FROZEN". THE STORAGE WAS CLEARED AND EPISODES WERE BEING RECORDED APPROPRIATELY. THE PHYSICIAN PLANNED ON CONTINUED USE OF THE DEVICE. THE PATIENT WAS STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10335031 ↗DeathMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Death
MAUDE report 10098227 ↗InjuryDec 20, 2019Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate
DURING A FOLLOW-UP IN CLINIC, THE DEVICE WAS UNABLE TO BE INTERROGATED DUE TO POSSIBLE PREMATURE BATTERY DEPLETION. 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 9503218 ↗InjuryDec 19, 2019Premature Discharge of Battery; Premature Discharge of Battery
DURING FOLLOW-UP, THERE WAS ALLEGED PREMATURE BATTERY DEPLETION NOTED ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9498374 ↗MalfunctionNov 11, 2019Failure to Interrogate; Interrogation Problem; Failure to Interrogate; Interrogation Problem
DURING FOLLOW-UP, AN INTERROGATION ANOMALY WAS NOTED ON THE DEVICE AND THE DEVICE WAS UNABLE TO BE INTERROGATED.. FURTHER INFORMATION WAS REQUESTED BUT NOT YET AVAILABLE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9305221 ↗MalfunctionOct 23, 2019Data Problem; Interrogation Problem; Data Problem; Interrogation Problem
WHILE INTERROGATING THE DEVICE DURING AN IN-CLINIC FOLLOW-UP, THE INTERROGATION SESSION CRASHED AND DEVICE DATA WAS UNABLE TO BE ACQUIRED. TECHNICAL SUPPORT WAS CONTACTED, AND SUSPECTED THIS ISSUE OCCURRED DUE TO THE DEVICE MEMORY BEING FULL. THE DEVICE RECEIVED A SOFTWARE UPGRADE TO RESOLVE THIS ISSUE. THE PATIENT WAS STABLE FOLLOWING THIS EVENT WITH NO ADVERSE HEALTH CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9224464 ↗MalfunctionAug 19, 2019Inappropriate or Unexpected Reset; Data Problem; Inappropriate or Unexpected Reset; Data Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR THE EXPLANT OF AN IMPLANTABLE CARDIAC MONITOR FOR NORMAL BATTERY DEPLETION. FOLLOWING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS IN BACKUP VVI, AND THE DATA COULD NOT BE READ. THE PATIENT DID NOT EXPERIENCE ANY CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8906760 ↗MalfunctionJun 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
DURING AN ELECTIVE DEVICE UPGRADE PROCEDURE, THE PHYSICIAN NOTED THE HEADER OF THE DEVICE BECAME DETACHED WHILE ATTEMPTING TO EXPLANT THE DEVICE. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8714176 ↗InjuryJun 7, 2019Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE WAS EXPLANTED TO RESOLVE THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8678634 ↗InjuryMay 24, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
DURING FOLLOW-UP, THE DEVICE WAS FOUND IN BACKUP MODE. THE DEVICE WAS EXPLANTED AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8640504 ↗MalfunctionFeb 11, 2019Data Problem; Data Problem
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS IMPLANTED IN 2014 OR 2015.
Patient problems: No Patient Involvement
MAUDE report 8327798 ↗InjuryJan 16, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
DURING A FOLLOW-UP, UPON INTERROGATION, THE DEVICE WAS FOUND IN BACKUP VVI MODE. A FIRMWARE RESET WAS ATTEMPTED BUT WAS UNSUCCESSFUL. NO FURTHER INTERVENTION WAS PERFORMED AT THIS TIME AND THE DEVICE WILL CONTINUE TO BE MONITORED UNTIL EXPLANT. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8252326 ↗MalfunctionJan 14, 2019Failure to Interrogate; Failure to Interrogate
DURING FOLLOW-UP, THE DEVICE WAS UNABLE TO BE INTERROGATED. THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8245378 ↗MalfunctionDec 13, 2018Communication or Transmission Problem; Communication or Transmission Problem
DURING FOLLOW-UP, AN ATTEMPT WAS MADE TO DOWNLOAD STORED EPISODES AND THE DEVICE SOFTWARE CRASHED. THE PHYSICIAN WILL ATTEMPT DOWNLOAD AT PATIENT'S NEXT FOLLOW-UP. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8161589 ↗MalfunctionNov 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: No Information
MAUDE report 8104515 ↗MalfunctionNov 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: No Information
MAUDE report 8104029 ↗MalfunctionNov 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: No Information
MAUDE report 8101647 ↗MalfunctionNov 20, 2018Premature Discharge of Battery; Premature Discharge of Battery
BEFORE THE INITIAL IMPLANT, THERE WAS PREMATURE BATTERY DEPLETION ALLEGED ON THE DEVICE. THE DEVICE WAS NOT IMPLANTED AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8090854 ↗InjuryNov 12, 2018Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR WAS EXPLANTED DUE TO AN UNKNOWN REASON. DURING THE PROCEDURE, THE HEADER OF THE DEVICE CAME OFF. NO FURTHER INFORMATION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8060961 ↗InjuryNov 12, 2018Difficult to Interrogate; Inappropriate or Unexpected Reset; Difficult to Interrogate; Inappropriate or Unexpected Reset
DURING A FOLLOW-UP IN CLINIC, THE DEVICE WAS INTERROGATED AND THE CONNECTION WAS LOST. ANOTHER ATTEMPT TO INTERROGATE THE DEVICE WAS MADE AND THE DEVICE WAS NOTED TO BE IN BACKUP MODE. NO INTERVENTION WAS PERFORMED AND THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8060726 ↗
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
- SJM CONFIRM™ DM2102St. Jude Medical, Inc. · RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)251 reports
- Assert-IQ™ DM5000St. Jude Medical, Inc. · Recorder, event, implantable cardiac, (without arrhythmia detection)226 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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