Current™ CD1211-36QRecalls & reported problems
St. Jude Medical, Inc. · Tiered-therapy cardioverter/defibrillatorVVEV VVIR · Class 3 · Implant
Quick summary
This St. Jude Medical Current defibrillator has 121 adverse event reports, with 4 deaths and 75 injuries. Many reports describe batteries reaching replacement level sooner than expected, failures to charge, and unexpected resets, and some describe inappropriate shocks from oversensing. 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
- 121
- Deaths reported
- 4
- Injuries reported
- 75
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 05414734503716), received between Jun 12, 2018 and Apr 11, 2026 — classified as 4 deaths, 75 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (25 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Premature Discharge of Battery25
- Failure to Charge19
- Inappropriate or Unexpected Reset17
- Inappropriate/Inadequate Shock/Stimulation14
- Over-Sensing14
- Failure to Interrogate9
- Adverse Event Without Identified Device or Use Problem8
- Delayed Charge Time7
Patient problems
- No Known Impact Or Consequence To Patient60
- No Clinical Signs, Symptoms or Conditions35
- Therapeutic Effects, Unexpected10
- Death4
- Unspecified Infection4
- Arrhythmia3
- No Consequences Or Impact To Patient3
- Complaint, Ill-Defined2
Recent adverse event reports
The 25 most recent of 121 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2026Premature Discharge of Battery
IT WAS REPORTED THAT THE BATTERY OF THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) LEVEL FASTER THAN EXPECTED. ABBOTT TECHNICAL SUPPORT REVIEWED DEVICE SESSION RECORDS AND COULD NOT CONFIRM PREMATURE BATTERY DEPLETION. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24847150 ↗InjuryAug 26, 2025Premature Discharge of Battery; Premature Discharge of Battery
DURING AN IN-CLINIC FOLLOW-UP, THE DEVICE WAS FOUND TO BE AT ELECTIVE REPLACEMENT INDICATOR (ERI) SOONER THAN EXPECTED. PREMATURE BATTERY DEPLETION IS SUSPECTED, ALTHOUGH NOT CONFIRMED. A DEVICE REPLACEMENT IS ANTICIPATED. THE PATIENT IS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22893733 ↗InjuryJun 5, 2025Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22154877 ↗MalfunctionNov 25, 2024Failure to Charge; Failure to Charge
IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, AN ALERT FOR CHARGE TIME LIMIT REACHED WAS NOTED ON THE DEVICE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED, HOWEVER, NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20776467 ↗MalfunctionOct 24, 2024Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, THE DEVICE WAS FOUND WITH BATTERY VOLTAGE AT ELECTIVE REPLACEMENT INDICATOR (ERI) LEVEL. THE PHYSICIAN SUSPECTED LONGEVITY OVERESTIMATION OCCURRED AT THE PREVIOUS FOLLOW UP IN CLINIC. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL ERI. NO INTERVENTION WAS REQUIRED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20529692 ↗InjuryMay 9, 2024Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PHYSICIAN CONSIDERED THE INAPPROPRIATE HIGH VOLTAGE THERAPY TO BE DUE TO THE PROGRAMMING. THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19281543 ↗InjuryMar 14, 2024Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT POST-SENSED T WAVE OVERSENSING WAS OBSERVED ON THE DEVICE, LEADING TO THE DELIVERY OF INAPPROPRIATE HIGH VOLTAGE THERAPY. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING, WHICH WAS PERFORMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: Discomfort
MAUDE report 18905283 ↗InjuryJan 5, 2024Failure to Charge; Failure to Charge
IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, AN ALERT FOR CAPACITOR CHARGE TIME LIMIT REACH WAS NOTED 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 18452506 ↗InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-52616 . RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-52617 . IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND RIGHT VENTRICULAR LEAD EXPLANTED DUE TO INFECTION. THE PATIENT'S CONDITION THROUGHOUT THE PROCEDURE WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 18146374 ↗MalfunctionSep 29, 2023Failure to Interrogate; Failure to Interrogate
DURING AN IN CLINIC FOLLOW UP, IT WAS OBSERVED THE RF TELEMETRY WAS DISABLED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND THE FIRMWARE WAS UPDATED, RESTORING THE RF TELEMETRY. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17842599 ↗MalfunctionSep 19, 2023Over-Sensing; Device Sensing Problem; Over-Sensing; Device Sensing Problem
DURING A CLINIC FOLLOW-UP, EPISODES OF POST-SENSED T WAVE OVERSENSING AND R WAVE AMPLITUDE VARIATION WERE OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17773632 ↗InjuryAug 11, 2023Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE WAS REPROGRAMMED TO INACTIVE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17509457 ↗MalfunctionJun 12, 2023Over-Sensing; Over-Sensing
IT WAS REPORTED THAT POST-PACED T WAVE OVERSENSING WAS OBSERVED ON THE DEVICE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING. THE DEVICE WAS EXPLANTED AND REPLACED DURING AN UNRELATED PROCEDURE. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17111005 ↗MalfunctionMar 17, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
DURING A CLINIC FOLLOW-UP, THE DEVICE WAS OBSERVED TO BE IN BACKUP (BVVI) MODE. 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 16566527 ↗MalfunctionFeb 14, 2023Failure to Charge; Failure to Charge
DURING REMOTE MONITORING, A CHARGE TIME OUT OCCURRED ON THE DEVICE DURING CAPACITOR MAINTENANCE. THE PATIENT WAS LATER SEEN IN-CLINIC AND THE DEVICE WAS ABLE TO FULLY CHARGE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED CONTINUED MONITORING AND DEVICE REPLACEMENT IF ANOTHER CHARGE TIME OUT OCCURS. 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 16371798 ↗MalfunctionFeb 3, 2023Failure to Convert Rhythm; Incorrect Interpretation of Signal; Failure to Convert Rhythm; Incorrect Interpretation of Signal
IT WAS REPORTED THAT THE DEVICE INCORRECTLY CLASSIFIED VENTRICULAR TACHYCARDIA AS SUPRAVENTRICULAR TACHYCARDIA DURING A REMOTE FOLLOW-UP. ADDITIONALLY, THE DEVICE WAS UNABLE TO TERMINATE THE VENTRICULAR TACHYCARDIA. THE PHYSICIAN DID NOT ALLEGE A MALFUNCTION AGAINST THE DEVICE. THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16297111 ↗MalfunctionOct 19, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED EXPERIENCING NO SYMPTOMS. UPON INTERROGATION, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND IN BACKUP VVI DUE TO A HARDWARE-RELATED RESET DISABLING DEFIBRILLATION THERAPY. NO INTERVENTION WAS PERFORMED AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15631966 ↗InjurySep 15, 2022Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED VIA INDUCTIVE AND RADIOFREQUENCY TELEMETRY PRIOR TO A DEVICE REPLACEMENT PROCEDURE. THE PHYSICIAN SUSPECTED THE EVENT COULD BE DUE TO THE DEVICE REACHING NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI) LEVEL, HOWEVER, STILL WANTED THE DEVICE TO BE INVESTIGATED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15429575 ↗InjuryJun 16, 2022Premature Discharge of Battery; Premature Discharge of Battery
DURING AN IN-CLINIC FOLLOW-UP, A RAPID DROP IN BATTERY DEPLETION WAS NOTED ON THE DEVICE. PREMATURE BATTERY DEPLETION WAS SUSPECTED. 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 14712382 ↗InjuryApr 18, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA (VT) AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT RECEIVED EXTERNAL DEFIBRILLATION TO RESOLVE THE VT. DEVICE INTERROGATION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IN BACKUP VVI. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO BATTERY EXHAUSTION. THE PATIENT WAS STABLE POST PROCEDURE.
Patient problems: Arrhythmia
MAUDE report 14136838 ↗InjuryApr 13, 2022Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) COULD NOT BE INTERROGATED INDUCTIVELY. THERE WAS NO CONSEQUENCES TO THE PATIENT. THE ICD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14102893 ↗InjuryFeb 16, 2022Charging Problem; Charging Problem
RELATED MANUFACTURER REPORT NUMBER: 2017865-2022-03436. DURING AN IN CLINIC FOLLOW UP, AN OCD (OVER CURRENT DETECTION) ALERT WAS RECEIVED ON THE DEVICE INDICATING A POSSIBLE HIGH VOLTAGE LEAD ISSUE ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SUPPORT WAS CONTACTED AND NOTED SHOCKS HAD NOT BEEN DELIVERED DUE TO HIGH DEFIBRILLATION IMPEDANCE ON THE RV LEAD. A LEAD FRACTURE WAS SUSPECTED. TECHNICAL SUPPORT RECOMMENDED LEAD AND DEVICE REPLACEMENT. THE RV LEAD AND THE DEVICE WERE EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13541201 ↗InjuryDec 14, 2021Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS OBSERVED THAT THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. THE ICD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13006740 ↗InjuryDec 1, 2021Failure to Convert Rhythm; Under-Sensing; Failure to Convert Rhythm; Under-Sensing
IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE SHOCKS DELIVERED DUE TO A VENTRICULAR TACHYCARDIA STORM. THE PATIENT ARRIVED AT THE HOSPITAL AND A MAGNET WAS PLACED OVER THE DEVICE AND EXTERNAL DEFIBRILLATION WAS DELIVERED. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND UNDERSENSING WAS OBSERVED DUE TO DEVICE PROGRAMMING. THERE WAS NO ALLEGED MALFUNCTION AGAINST THE DEVICE, THE R WAVE SIGNAL WAS VERY SMALL AT THE TIME OF UNDERSENSING. THE PATIENT ALSO EXPERIENCED A DELAY IN THERAPY DUE TO UNDERSENSING; HOWEVER, SINCE THE PATIENT HAD A VT STORM, MULTIPLE HIGH VOLTAGE SHOCKS WERE DELIVERED IN A SHORT AMOUNT OF TIME. THE PATIENT RECEIVED AN UPGRADED TRIPLE CHAMBER DEVICE TO RESOLVE THE EVENT.
Patient problems: Arrhythmia; No Clinical Signs, Symptoms or Conditions
MAUDE report 12909232 ↗InjuryOct 31, 2021Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. THE ICD WAS EXPLANTED AND REPLACED. PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12725578 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.