FORTIFY™ CD1231-40Recalls & reported problems
St. Jude Medical, Inc. · Tiered-therapy cardioverter/defibrillatorVVEV VVIR · Class 3 · Implant
Quick summary
This St. Jude Medical Fortify defibrillator is an implanted heart device that delivers shocks to correct abnormal heart rhythms. Its 333 reports mostly describe early battery depletion, the device switching into a backup mode (sometimes during MRI scans) and unexpected resets. The reports mention 7 deaths and 253 injuries, with some deaths linked to heart disease or an unknown cause. 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
- 333
- Deaths reported
- 7
- Injuries reported
- 253
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 333 adverse event reports that list this exact device (DI 05414734504355), received between Jun 18, 2018 and Apr 15, 2026 — classified as 7 deaths, 253 injuries, 73 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (99 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
- Battery Problem99
- Premature Discharge of Battery90
- Adverse Event Without Identified Device or Use Problem58
- Inappropriate or Unexpected Reset39
- Inappropriate/Inadequate Shock/Stimulation28
- Failure to Interrogate22
- Failure to Charge15
- Over-Sensing13
Patient problems
- No Known Impact Or Consequence To Patient131
- No Clinical Signs, Symptoms or Conditions121
- Unspecified Infection31
- No Consequences Or Impact To Patient14
- Pocket Erosion12
- Discomfort11
- Therapeutic Effects, Unexpected10
- Arrhythmia9
Recent adverse event reports
The 25 most recent of 333 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 15, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND TO BE IN BACKUP OPERATION DUE TO PATIENT HAVING AN MRI EXAMINATION. PROGRAMMING CHANGES WERE PERFORMED TO RESTORE THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887966 ↗MalfunctionFeb 17, 2026Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. A DEVICE INTERROGATION WAS PERFORMED AND REVEALED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369366 ↗DeathJan 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DIED DUE TO CARDIOPULMONARY ARREST. IT IS UNKNOWN WHETHER THE PATIENT'S CAUSE OF DEATH IS DEVICE OR PROCEDURE RELATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24182606 ↗MalfunctionDec 8, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WENT INTO BACKUP OPERATION DUE TO SUSPECTED RADIOFREQUENCY ABLATION. PROGRAMMING CHANGES WERE MADE TO RESET THE DEVICE. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744157 ↗DeathNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT IS DECEASED. THERE IS NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS CARDIOVASCULAR DISEASE.
Patient problems: Insufficient Information
MAUDE report 23538859 ↗MalfunctionOct 27, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT DURING AN IN-CLINIC CHECK, THE DEVICE WAS FOUND TO BE IN BACKUP VVI RESET MODE WITH NO BACKUP DEFIBRILLATION FUNCTION ON (BDFO). A DEVICE RESTORATION WAS PERFORMED SUCCESSFULLY AND REPROGRAMMED. THE PATIENT WAS IN STABLE CONDITION WITH NO ADVERSE HEALTH CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23390379 ↗InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC WITH REDNESS AND SWELLING ON THE POCKET SITE. IT WAS ALSO NOTED THAT LEAD ERODED. THE PHYSICIAN DID NOT ALLEGE THAT THE INFECTION WAS RELATED TO THE PRODUCT NOR THE PROCEDURE. THE ENTIRE SYSTEM WAS EXPLANTED. THE PATIENT WAS STABLE.
Patient problems: Unspecified Infection
MAUDE report 23001665 ↗MalfunctionAug 6, 2025Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT UNDERWENT A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE. IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACKUP MODE DUE TO THE MRI. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22729104 ↗InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED WOUND DEHISCENCE AND INFECTION AT THE DEVICE POCKET. IT WAS NOTED THAT THE PATIENT'S DEVICE HAD ERODED THROUGH THE SKIN. THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025 WHILE THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DURING THE SAME PROCEDURE DUE TO THE INFECTION. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.
Patient problems: Pocket Erosion; Unspecified Infection; Wound Dehiscence
MAUDE report 22561722 ↗MalfunctionJul 7, 2025Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED BACK UP OPERATION DUE TO OFF LABEL USE AND LOSS OF DEFIBRILLATION THERAPY ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22428783 ↗InjuryJul 6, 2025Premature Discharge of Battery; Failure to Interrogate; No Pacing; Premature Discharge of Battery; Failure to Interrogate; No Pacing
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH A COMPLAINT OF DIZZINESS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED AND THE WAS NO OBSERVABLE PACING OUTPUT. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: Dizziness
MAUDE report 22408427 ↗MalfunctionJun 25, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACKUP MODE. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS REPORTED TO LATER DECEASE DUE TO ORGAN FAILURE. THERE WERE NO ALLEGATIONS THAT THE PATIENT'S DEATH WAS CAUSED OR CONTRIBUTED TO BY AN ABBOTT DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22331659 ↗InjuryJun 9, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE DISCHARGE OF BATTERY. THE ICD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22172642 ↗InjuryMay 2, 2025Failure to Convert Rhythm; Failure to Convert Rhythm
IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL SEVERAL TIMES FOR RESCUE DUE TO CARDIAC DISCOMFORT AFTER IMPLANT. IT WAS REPORTED THAT ONLY ONE DISCHARGE MAY HAVE BEEN DELIVERED WITH NO EFFECT IN (B)(6) 2024 DURING THE 4YRS OF IMPLANT. SUBSEQUENT INFORMATION RECEIVED NOTES THAT THE DEVICE DELIVERED TREATMENT CORRECTLY, BUT ONLY SLOWED DOWN VENTRICULAR TACHYCARDIA (VT), DID NOT RESTORE SINUS RHYTHM AND EXTERNAL DEFIBRILLATION HAD TO BE USED TO RESTORE SINUS RHYTHM. DEFIBRILLATION THRESHOLDS WERE HIGH, PROGRAMMING CHANGES WERE MADE TO THE DEFIBRILLATION SLOPE, DIAGNOSTIC INTERVAL AND OTHER VECTORS TO ADDRESS THE ISSUE. THE PATIENT WAS STABLE.
Patient problems: Arrhythmia; Discomfort
MAUDE report 21955461 ↗MalfunctionApr 30, 2025Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WENT INTO BVVI MODE. UPON FURTHER INQUIRY, WAS INFORMED THAT THE PATIENT HAD UNDERGONE AN MRI SCAN. THE DEVICE WAS RESTORED. THE BACKUP THERAPY WAS NOT AVAILABLE. THE PATIENT IS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21934447 ↗MalfunctionApr 20, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. UPON REVIEW, IT WAS DISCOVERED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED PREMATURE BATTERY DEPLETION. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21870307 ↗InjuryMar 7, 2025Premature Discharge of Battery; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Premature Discharge of Battery; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT INAPPROPRIATE THERAPY WAS DELIVERED BY THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO INCORRECT INTERPRETATION OF THE PATIENT'S RHYTHM BY THE DEVICE. THE PHYSICIAN BELIEVED THAT THE BATTERY DEPLETED PREMATURELY AS WELL. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THE PATIENT IS RECOVERING AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21547578 ↗InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 2017865-2024-71513. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH WOUND DEHISCENCE. UPON FURTHER INSPECTION, THE POCKET WAS INFECTED HAD SECRETIONS AND BLISTERS. THE ENTIRE IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 20829058 ↗MalfunctionNov 9, 2024Failure to Charge; Failure to Charge
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED CHARGE TIME OUT AND INFECTION ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). NO CHANGES OR INTERVENTION WERE REPORTED. THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20648126 ↗InjuryNov 8, 2024Failure to Convert Rhythm; Inappropriate or Unexpected Reset; Failure to Convert Rhythm; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ARRHYTHMIA. UPON REVIEW, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED HIGH VOLTAGE THERAPY BUT THE PATIENT'S RHYTHM WAS UNABLE TO BE CONVERTED. THE PATIENT RECEIVED EXTERNAL DEFIBRILLATION ON (B)(6) 2024 AND THE ARRHYTHMIA WAS SUCCESSFULLY CONVERTED. ON (B)(6) 2024, THE ICD WAS FOUND TO BE IN BACK-UP MODE WITH NO BACK-UP DEFIBRILLATION OPTION (BDFO) AVAILABLE. THE ICD WAS SUCCESSFULLY RESTORED. ON (B)(6) 2024, THE ICD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Arrhythmia
MAUDE report 20645797 ↗InjuryMay 24, 2024Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE AND ASYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19397308 ↗InjuryMar 18, 2024Premature Discharge of Battery; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Premature Discharge of Battery; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INAPPROPRIATE SHOCK DUE TO INCORRECT INTERPRETATION OF SIGNAL DURING ATRIAL FIBRILLATION EPISODES. PREMATURE BATTERY DEPLETION WAS ALSO NOTED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18926949 ↗InjuryJan 29, 2024Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THE PATIENT PRESENTED WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IN BACKUP MODE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS NOT ABLE TO BE RESTORED AND WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18602994 ↗InjuryJan 25, 2024Premature Discharge of Battery; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset; Premature Discharge of Battery; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED. IT WAS NOTED THAT THERE WAS INAPPROPRIATE THERAPY AND PREMATURE BATTERY DEPLETION. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18581536 ↗InjuryJan 3, 2024Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED, THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS DISCOVERED, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DELIVERED INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION (AF), WITH RAPID VENTRICULAR RESPONSE (RVR). NO CHANGES OR INTERVENTIONS WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18441423 ↗
Other Pulse generator, permanent, implantable devices
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- Edora 8 DR-T 407145BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable10 deaths982 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.