Current™ CD1211-36Recalls & reported problems
St. Jude Medical, Inc. · Tiered-therapy cardioverter/defibrillatorVVEV VVIR · Class 3 · Implant
All models of Current (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Current CD1211-36 is an implantable cardioverter/defibrillator, a pacemaker-like pulse generator implanted under the skin to keep the heart rhythm steady and deliver shocks when needed. The 76 reports mostly describe the battery running down sooner than expected, shocks delivered when the heart rhythm did not call for them, the unit resetting itself into a backup mode on its own, and charging that took too long or failed. Reports mention 2 deaths and 45 injuries. 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
- 76
- Deaths reported
- 2
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 05414734503686), received between Jun 13, 2018 and Oct 20, 2025 — classified as 2 deaths, 45 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (13 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
- Inappropriate/Inadequate Shock/Stimulation13
- Premature Discharge of Battery13
- Inappropriate or Unexpected Reset12
- Failure to Charge8
- Delayed Charge Time7
- Adverse Event Without Identified Device or Use Problem6
- Over-Sensing5
- Energy Output Problem4
Patient problems
- No Known Impact Or Consequence To Patient38
- No Clinical Signs, Symptoms or Conditions21
- Therapeutic Effects, Unexpected11
- No Consequences Or Impact To Patient4
- No Information3
- Death2
- Atrial Fibrillation1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE IN BACKUP VVI MODE UPON INTERROGATION. NO INTERVENTION WAS PERFORMED, AND THE PATIENT'S STATUS WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23343538 ↗InjuryNov 20, 2024Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
DURING AN IN-CLINIC FOLLOW-UP, EPISODES OF ATRIAL FIBRILLATION (AF) WERE OBSERVED ON THE DEVICE. THE AF WAS INCORRECTLY INTERPRETED BY THE DEVICE WHICH RESULTED IN DELIVERY OF INAPPROPRIATE SHOCK. ABBOTT TECHNICAL SUPPORT WAS CONTACTED, AND THE DEVICE WAS REPROGRAMMED TO AVOID ANY FUTURE EPISODES OF INAPPROPRIATE SHOCK. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20734942 ↗MalfunctionJul 6, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE DEVICE WAS FOUND IN BACK-UP MODE FOLLOWING THE DELIVERY OF APPROPRIATE HIGH VOLTAGE THERAPY. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17275574 ↗MalfunctionJun 23, 2023Premature Discharge of Battery; Incorrect Measurement; Premature Discharge of Battery; Incorrect Measurement
ADDITIONAL INFORMATION WAS RECEIVED THAT TECHNICAL SUPPORT WAS CONTACTED AND IT WAS DETERMINED THAT THE CHANGE IN THE DEVICE LONGEVITY WAS DUE TO A DIAGNOSTIC ANOMALY, AND NOT DUE TO PREMATURE BATTERY DEPLETION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17191149 ↗InjuryFeb 1, 2023Premature Discharge of Battery; Premature Discharge of Battery
DURING AN IN CLINIC FOLLOW UP, UPON INTERROGATION THE LONGEVITY WAS LESS THAN EXPECTED FROM THE PREVIOUS FOLLOW UP 7 MONTHS AGO. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16279500 ↗InjurySep 29, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
DURING AN IN CLINIC FOLLOW UP, IT WAS NOTED THE DEVICE WAS IN BACK UP MODE. TECHNICAL SUPPORT WAS CONTACTED AND SUSPECTED BATTERY WAS LOW AND ERI (ELECTIVE REPLACEMENT INDICATOR) HAD BEEN REACHED. IT WAS NOTED A DEVICE FIRMWARE DOWNLOAD WAS CARRIED OUT. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15506794 ↗InjuryApr 19, 2022Failure to Charge; Failure to Charge
PATIENT PRESENTED IN-CLINIC AFTER A CHARGE TIME OUT OCCURRED ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14142505 ↗MalfunctionMar 19, 2022Incorrect Measurement; Incorrect Measurement
DURING AN IN-CLINIC FOLLOW-UP, THE PHYSICIAN DISCOVERED THE DEVICE HAD PREVIOUSLY DELIVERED A SHORTED OUTPUT STAGE DETECTION (SOSD) ALERT, HOWEVER, THE DEVICE HAD BEEN FUNCTIONING NORMALLY SINCE THE ALERT. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND SUSPECTED THE SOSD ALERT WAS FALSE. REPROGRAMMING IS ANTICIPATED TO RESOLVE THE EVENT, HOWEVER, NO INTERVENTION WAS PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13826021 ↗MalfunctionMar 18, 2022Failure to Charge; Data Problem; Failure to Charge; Data Problem
DURING FOLLOW-UP, A WARNING FOR SHORTED OUTPUT STAGE DETECTION (SOSD) WAS OBSERVED ON THE DEVICE. THE DEVICE HAD DELIVERED APPROPRIATE HIGH VOLTAGE THERAPY PREVIOUSLY. NO INTERVENTION WAS PERFORMED; 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 13810077 ↗MalfunctionSep 24, 2021Over-Sensing; Over-Sensing
DURING A REMOTE FOLLOW-UP, POST-SENSED T-WAVE OVERSENSING WAS OBSERVED ON THE DEVICE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED 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 12525721 ↗InjurySep 17, 2021Failure to Charge; Failure to Charge
DURING DEVICE TESTING, A CAPACITOR CHARGE TIME LIMIT WAS REACHED ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12492415 ↗InjurySep 16, 2021Tactile Prompts/Feedback; Tactile Prompts/Feedback
IT WAS REPORTED THAT PATIENT PRESENTED FOR ROUTINE FOLLOW UP. THE PATIENT NOTED A LACK OF VIBRATORY ALERT FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12485642 ↗InjuryAug 16, 2021Failure to Charge; Failure to Charge
IT WAS REPORTED THAT AN EXTENDED CHARGE TIME RESULTING IN A CHARGE TIME OUT WAS OBSERVED ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12328118 ↗InjuryMay 27, 2021Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
ADDITIONAL INFORMATION RECEIVED INDICATED THE EVENT WAS RESOLVED BY EXPLANTING AND UPGRADING THE PATIENT'S REPLACEMENT DEVICE TO A DUAL CHAMBER DEVICE AND IMPLANTING A RIGHT ATRIAL LEAD. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11893619 ↗MalfunctionApr 22, 2021Failure to Convert Rhythm; Failure to Convert Rhythm
IT WAS REPORTED THAT DEVICE DELIVERED INADEQUATE ANTI-TACHYCARDIA PACING (ATP) DURING AN EPISODE OF VENTRICULAR TACHYCARDIA, WHICH ACCELERATED TO VENTRICULAR FIBRILLATION (VF) FOLLOWING THE ATP. THE DEVICE DELIVERED AN APPROPRIATE SHOCK TO TERMINATE THE VF EPISODE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING THE DEVICE TO MORE ACCURATELY DIAGNOSE ARRHYTHMIAS, WHICH WAS ANTICIPATED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11711755 ↗MalfunctionFeb 26, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-09572. DURING AN IN CLINIC FOLLOW-UP, THE DEVICE WAS FOUND TO BE IN BACK-UP VVI MODE. IT WAS ALSO NOTED THAT OVERSENSING AND DECREASED PACING IMPEDANCE WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. INSULATION DAMAGE WAS SUSPECTED BUT WAS NOT CONFIRMED. TECHNICAL SUPPORT WAS CONTACTED AND A FIRMWARE DOWNLOAD WAS PERFORMED TO RESOLVE THE BACK-UP VVI. IT WAS SUSPECTED THAT THE OVERSENSING ON THE RV LEAD MAY HAVE CONTRIBUTED TO THE BACK-UP VVI MODE ON THE DEVICE. THE DEFIBRILLATION THERAPY WAS DISABLED AS AN INTERIM RESOLUTION AND AN RV LEAD REPLACEMENT PROCEDURE AND DEVICE EXCHANGE IS ANTICIPATED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11387015 ↗InjuryJan 7, 2021Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate
DURING A CLINIC FOLLOW-UP, 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11135630 ↗InjuryOct 30, 2020Failure to Charge; Failure to Charge
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020-16896. IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED TO THE EMERGENCY ROOM FOR A VIBRATORY ALERT THAT THEY HAD RECEIVED FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR CAPACITOR TIME LIMIT REACHED AND HIGH OUT OF RANGE DEFIBRILLATION IMPEDANCE FOR THE RIGHT VENTRICULAR (RV) LEAD. ICD WAS EXPLANTED AND REPLACED ON (B)(6)2020. THE EXISTING RV LEAD HAD NORMAL MEASUREMENTS AT FIRST BUT THEN EXHIBITED HIGH DEFIBRILLATION IMPEDANCE AGAIN. RV LEAD WAS INSTEAD CAPPED AND REPLACED. AN X-RAY REVEALED THE LEAD HAD EXTERNALIZED CONDUCTORS. PATIENT WAS STABLE AFTER THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10766771 ↗InjuryOct 9, 2020Incorrect Measurement; Incorrect Measurement
DURING A FOLLOW-UP IN CLINIC, THE DEVICE WAS NOTED TO BE AT ELECTIVE REPLACEMENT INDICATOR (ERI) SOONER THAN EXPECTED. AN OVERESTIMATION OF BATTERY LONGEVITY BY THE PROGRAMMER AT THE PREVIOUS FOLLOW-UP WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10659102 ↗InjuryOct 8, 2020Failure to Charge; Failure to Charge
ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THERE WERE NO KNOWN PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10652552 ↗MalfunctionSep 15, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
DURING AN IN-CLINIC FOLLOW UP, THE DEVICE WAS FOUND IN BACK UP MODE DUE TO A POWER-ON-RESET. TECHNICAL SUPPORT WAS CONTACTED AND IT WAS SUSPECTED THAT CAUSE OF THE EVENT WAS DUE TO THE MULTIPLE HIGH VOLTAGE THERAPIES DELIVERED TO THE PATIENT WHICH CAUSED THE DEVICE BATTERY TO DEPLETE AND RUN LOW. DEVICE REPROGRAMMING WAS CONDUCTED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10538480 ↗InjurySep 1, 2020Premature Discharge of Battery; Premature Discharge of Battery
PREMATURE BATTERY DEPLETION WAS SUSPECTED AS THE TIME FROM ELECTIVE REPLACEMENT INDICATOR (ERI) TO END OF LIFE (EOL) WAS SHORTER THAN EXPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10477253 ↗InjuryAug 17, 2020Migration or Expulsion of Device; Low Sensing Threshold; Migration or Expulsion of Device; Low Sensing Threshold
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020-11562. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE GENERATOR CHANGE. UPON INTERROGATION, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED LOW R-WAVE SENSING ON THE RIGHT VENTRICULAR LEAD. IT WAS NOTED THAT THE PATIENT HAD OCCASIONALLY TWIDDLED WITH THEIR DEVICE AND MOVED THE DEVICE IN THE POCKET. DURING THE PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR LEAD HAD PULLED BACK AND THERE WAS OUTER INSULATION DAMAGE DUE TO THE LEAD RUBBING AGAINST THE DEVICE. THE LOW R-WAVES WAS BELIEVED TO BE DUE TO THE DEVICE PULLING BACK THE LEAD WHEN IT WAS MOVED IN THE POCKET. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. PATIENT WAS STABLE.
Patient problems: Twiddlers Syndrome
MAUDE report 10415820 ↗InjuryAug 14, 2020Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate
DURING A PREVIOUS FOLLOW-UP IN JUNE, THE DEVICE LONGEVITY WAS ESTIMATED TO BE AT 2-4 YEARS. IN JULY, THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS OBSERVED ON THE DEVICE. AT AN IN-CLINIC FOLLOW UP, THE DEVICE WAS NOT ABLE TO BE INTERROGATED WITH A PROGRAMMER. TECHNICAL SUPPORT WAS CONTACTED AND NOTED A DROP IN BATTERY VOLTAGE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10407006 ↗DeathAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 2017865-2020-10385. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2020. THERE IS NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS A HEART ATTACK. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Death
MAUDE report 10358101 ↗
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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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