Promote™ CD3211-36Recalls & reported problems
St. Jude Medical, Inc. · Cardiac resynchronization device, tiered-therapy cardioverter/defibrillatorVVED DDDRV · Class 3 · Implant
All models of Promote (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05414734503693), received between Jun 13, 2018 and Aug 17, 2021 — classified as 12 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (7 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.
Most reported problems
Device problems
- Premature Discharge of Battery7
- Adverse Event Without Identified Device or Use Problem2
- Failure to Interrogate2
- Inappropriate or Unexpected Reset2
- Inappropriate/Inadequate Shock/Stimulation2
- Over-Sensing2
- Separation Failure2
- Battery Problem1
Patient problems
- No Known Impact Or Consequence To Patient12
- No Clinical Signs, Symptoms or Conditions3
- Therapeutic Effects, Unexpected2
- No Consequences Or Impact To Patient1
- No Information1
- Unspecified Infection1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
BACKUP OPERATION WAS REPORTED ON THE DEVICE. THE DEVICE WAS EXPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12332780 ↗InjuryApr 6, 2021Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate
DURING A FOLLOW-UP, THE DEVICE COULD NOT BE INTERROGATED DUE TO BEING AT END OF LIFE (EOL). PREMATURE BATTERY DEPLETION WAS ALLEGED. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11624570 ↗InjuryMar 8, 2021Battery Problem; Battery Problem
ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11441070 ↗MalfunctionOct 18, 2020Separation Failure; Separation Failure
RELATED MANUFACTURER REPORT NUMBER: 2017865-2020-15689. DURING A DEVICE REPLACEMENT PROCEDURE, THE SET SCREW ON THE DEVICE HEADER WAS LOOSENED COMPLETELY TO ALLOW THE REMOVAL THE LEFT VENTRICULAR (LV) LEAD. THE PHYSICIAN PULLED ON THE LV LEAD, BUT THE LV LEAD WAS UNABLE TO BE REMOVED. THE PULLING RESULTED IN A FRACTURING OF THE LV LEAD. THE LV LEAD WAS CAPPED AND THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10695100 ↗MalfunctionAug 26, 2020Failure to Charge; Failure to Charge
DURING A REMOTE FOLLOW-UP, THE DEVICE ALERT OF CHARGE TIME LIMIT ON THE CAPACITOR WAS OBSERVED. THE DEVICE WAS REACHING NORMAL END OF LIFE AND A REPLACEMENT PROCEDURE IS ANTICIPATED. THE PATIENT WAS STABLE AND WILL CONTINUE BEING MONITORED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10457240 ↗MalfunctionJan 3, 2020High impedance; High impedance
DURING AN IN-CLINIC FOLLOW UP, INCREASE IN PACING IMPEDANCE WAS NOTED ON THE ON THE LEFT VENTRICULAR (LV) CHANNEL. THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9548092 ↗InjuryDec 4, 2019Premature Discharge of Battery; Premature Discharge of Battery
DURING FOLLOW-UP, IT WAS NOTED THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS EXPLANTED AND REPLACED DUE TO SUSPECTED PREMATURE BATTERY DEPLETION. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9410753 ↗MalfunctionSep 27, 2019Separation Failure; Separation Failure
DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE, THE RIGHT ATRIAL LEAD WAS UNABLE TO BE REMOVED FROM THE DEVICE HEADER. 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 9129911 ↗InjurySep 24, 2019Premature Discharge of Battery; Premature Discharge of Battery
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-14106. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH LOSS OF CAPTURE ON THE RIGHT VENTRICULAR LEAD. PROGRAMMING CHANGES WERE MADE, AND IT WAS NOTED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. ON (B)(6)2013 THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR THRESHOLDS AND IMPEDANCES WERE ELEVATED. THE RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED ON (B)(6) 2013.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9111029 ↗MalfunctionApr 11, 2019Over-Sensing; Over-Sensing
DURING A FOLLOW-UP, NOISE CAUSING AUTOMATIC MODE SWITCH (AMS) ON THE DEVICE WAS NOTED. THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8504948 ↗InjuryMar 28, 2019Premature Discharge of Battery; Premature Discharge of Battery
DURING FOLLOW-UP, THE DEVICE WAS FOUND TO HAVE REACHED ITS ELECTIVE REPLACEMENT INDICATOR (ERI) PREMATURELY. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8462406 ↗InjuryMar 13, 2019Incorrect Measurement; Incorrect Measurement
DURING FOLLOW-UP IN CLINIC, IT WAS NOTED THAT THE MERLIN PROGRAMMER MADE AN OVERESTIMATION OF THE LONGEVITY OF THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED AND THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8418261 ↗MalfunctionMar 6, 2019Over-Sensing; Over-Sensing
DURING FOLLOW-UP, INTERMITTENT PACING INHIBITION DUE TO CROSSTALK WAS OBSERVED. TECHNICAL SUPPORT WAS CONTACTED AND SUGGESTED REPROGRAMMING THE DEVICE TO RESOLVE THE ISSUE. REPROGRAMMING IS ANTICIPATED TO BE PERFORMED AT FOLLOW-UP. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8397342 ↗InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO A POCKET INFECTION. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Patient problems: Unspecified Infection
MAUDE report 8323312 ↗InjuryJan 17, 2019Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
DURING FOLLOW-UP, THE PHYSICIAN NOTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO INCORRECT DETECTED OF ATRIAL FIBRILLATION AS A TACHYCARDIA EVENT. NO INTERVENTION WILL BE PERFORMED AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Therapeutic Effects, Unexpected
MAUDE report 8257919 ↗MalfunctionDec 13, 2018Premature Discharge of Battery; Premature Discharge of Battery
DURING FOLLOW-UP, THE DEVICE WAS INTERROGATED AND THE ESTIMATED LONGEVITY WAS LESS THAN EXPECTED. THE PHYSICIAN ALLEGED PREMATURE BATTERY DEPLETION. NO INTERVENTION WAS PERFORMED AND THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8162432 ↗InjuryDec 11, 2018Premature Discharge of Battery; Premature Discharge of Battery
DURING FOLLOW-UP, THE DEVICE WAS INTERROGATED FOUND IN ERI. THE PHYSICIAN SUSPECTED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8151962 ↗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 8104031 ↗InjurySep 13, 2018Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate
DURING A FOLLOW-UP IN CLINIC, THERE WAS AN UNEXPECTED DECREASE IN REMAINING LONGEVITY OF THE DEVICE. PREMATURE BATTERY DEPLETION WAS SUSPECTED. DEVICE REPLACEMENT IS ANTICIPATED AND THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7873610 ↗InjuryJun 13, 2018Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IN BACKUP VVI. IT WAS ALSO NOTED THAT THE PATIENT MAY HAVE RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY BUT THEY WERE UNABLE TO CONFIRM IT DUE TO THE LOW BATTERY STATUS OF THE DEVICE. A DEVICE DOWNLOAD COULD NOT BE PERFORMED DUE TO THE LOW BATTERY STATUS. ON (B)(6) 2018, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR. PATIENT WAS IN GOOD CONDITION THROUGHOUT.
Patient problems: Therapeutic Effects, Unexpected
MAUDE report 7597179 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- Gallant™ CDHFA500QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 recalls58 deaths8,401 reports
- Quartet™ 1458Q-86St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)207 deaths6,631 reports
- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls40 deaths1,639 reports
- Unify Assura™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 reports
- Unify Assura™ CD3357-40CSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)56 deaths1,588 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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