Promote™ CD3211-36QRecalls & reported problems
St. Jude Medical, Inc. · Cardiac resynchronization device, tiered-therapy cardioverter/defibrillatorVVED DDDRV · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Promote CRT-D implantable defibrillator has 42 adverse event reports, including 3 deaths and 23 injuries. Reports mostly describe the battery draining sooner than expected, sensing errors on the leads, and devices that could not be checked in clinic, often leading to removal and replacement. 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
- 42
- Deaths reported
- 3
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 05414734503679), received between Jun 11, 2018 and Mar 5, 2024 — classified as 3 deaths, 23 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (16 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 Battery16
- Over-Sensing7
- Incorrect Measurement5
- Inappropriate or Unexpected Reset3
- Inappropriate/Inadequate Shock/Stimulation3
- Adverse Event Without Identified Device or Use Problem2
- Failure to Deliver Shock/Stimulation2
- Failure to Interrogate2
Patient problems
- No Known Impact Or Consequence To Patient24
- No Clinical Signs, Symptoms or Conditions9
- Death3
- Therapeutic Effects, Unexpected3
- Cardiac Arrest1
- Complaint, Ill-Defined1
- No Consequences Or Impact To Patient1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Signal Artifact/Noise; Pacing Problem; Signal Artifact/Noise; Pacing Problem
IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE DEVICE. THE NOISE LED TO OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD. INAPPROPRIATE AUTOMATIC MODE SWITCH WAS ALSO OBSERVED. THE CAUSE OF THE NOISE WAS SUSPECTED TO BE DUE TO ELECTROMAGNETIC INTERFERENCE. LEAD DAMAGE ON THE RV LEAD AND RA LEAD WAS ALSO SUSPECTED BUT NOT CONFIRMED VISUALLY. NO INTERVENTION WAS PERFORMED; THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE CONSEQUENCES. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2024-34130, 2017865-2024-34132.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18837765 ↗InjuryApr 27, 2023Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED VIA INDUCTIVE TELEMETRY DURING AN IN CLINIC FOLLOW-UP. 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 16822839 ↗MalfunctionMar 1, 2023Defective Device; Defective Device
DURING A ROUTINE DEVICE EXCHANGE, THE DEVICE WAS EXPLANTED AND A PORTION OF THE HEADER DETACHED ON THE TABLE. THE NEW DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16463522 ↗MalfunctionFeb 13, 2023Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, THE DEVICE WAS FOUND TO HAVE REACHED END OF LIFE (EOL) BATTERY VOLTAGE. AT THE PREVIOUS INTERROGATION, APPROXIMATELY 14 MONTHS PRIOR, THE LONGEVITY ESTIMATION ON THE BATTERY WAS MORE THAN 2 YEARS TO ELECTIVE REPLACEMENT INDICATOR (ERI) LEVEL. THE PHYSICIAN SUSPECTED THE BATTERY DEPLETION WAS NORMAL AND LONGEVITY OVERESTIMATION OCCURRED AT THE PREVIOUS FOLLOW UP. THE DEVICE WAS EXPLANTED DUE TO NORMAL ERI/EOL AND WAS REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16368513 ↗InjuryNov 11, 2022Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT A DECREASE IN THE BATTERY LONGEVITY WAS OBSERVED AND PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15777712 ↗MalfunctionMay 6, 2022Incorrect Measurement; Incorrect Measurement
DURING A CLINIC FOLLOW-UP, A DECREASE IN THE BATTERY LONGEVITY WAS NOTED ON THE DEVICE AND IT WAS SUSPECTED THAT THERE WAS AN OVERESTIMATION OF THE DEVICE LONGEVITY AT A PREVIOUS FOLLOW-UP. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS EXPLANTED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI) AND REPLACED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14310572 ↗InjuryDec 6, 2021Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT A DROP IN ESTIMATED BATTERY LONGEVITY 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 12933473 ↗InjurySep 20, 2021Failure to Charge; Failure to Charge
ADDITIONAL INFORMATION WAS RECEIVED INDICATING 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 12501639 ↗MalfunctionAug 13, 2021Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT AN INACCURATE DROP IN BATTERY VOLTAGE WAS OBSERVED ON THE DEVICE DURING FOLLOW-UP. ABBOTT TECHNICAL SUPPORT WAS CONTACTED BUT THE CAUSE OF THE DROP IN BATTERY VOLTAGE COULD NOT BE DETERMINED. 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 12320957 ↗InjuryDec 8, 2020Premature Discharge of Battery; Premature Discharge of Battery
A DECREASE IN THE DEVICE BATTERY LONGEVITY WAS REPORTED AND POSSIBLE PREMATURE BATTERY DEPLETION WAS SUSPECTED. 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 10970189 ↗MalfunctionDec 4, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
THE PATIENT PRESENTED IN CLINIC AFTER RECEIVING INAPPROPRIATE DEFIBRILLATION THERAPY FOR SUPRAVENTRICULAR TACHYCARDIA. THE PHYSICIAN DID NOT ALLEGE A MALFUNCTION AGAINST THE DEVICE AND STATED THE DEVICE PERFORMED AS EXPECTED BASED UPON ITS PROGRAMMED SETTINGS. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Therapeutic Effects, Unexpected
MAUDE report 10945235 ↗InjuryJul 28, 2020Premature Discharge of Battery; Incorrect Measurement; Premature Discharge of Battery; Incorrect Measurement
DURING FOLLOW-UP, PREMATURE BATTERY DEPLETION WAS SUSPECTED. SESSION RECORDS WERE SENT TO ABBOTT TECHNICAL SUPPORT FOR REVIEW WHICH INDICATED A BATTERY LONGEVITY OVERESTIMATION BY THE PROGRAMMER. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10332319 ↗InjuryJul 23, 2020Premature Discharge of Battery; Incorrect Measurement; Premature Discharge of Battery; Incorrect Measurement
DURING FOLLOW-UP, PREMATURE BATTERY DEPLETION WAS SUSPECTED. SESSION RECORDS WERE SENT TO ABBOTT TECHNICAL SUPPORT FOR REVIEW WHICH INDICATED A BATTERY LONGEVITY OVERESTIMATION BY THE PROGRAMMER. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10316854 ↗MalfunctionJun 26, 2020Over-Sensing; Over-Sensing
DURING AN IN CLINIC FOLLOW-UP, POST-PACED T-WAVE OVERSENSING WAS NOTED ON THE DEVICE. 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 10203360 ↗InjuryJun 18, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR REMOTE FOLLOW UP VIA MERLIN.NET WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IN BACKUP OPERATION. THE PHYSICIAN ELECTIVELY DECIDED TO REPLACE THE DEVICE SINCE IT WAS LESS THAN TWO YEARS FROM THE TRIGGERED ELECTIVE REPLACEMENT INDICATOR. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS NOT PACEMAKER DEPENDENT AND WAS DISCHARGED POST-PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10167962 ↗MalfunctionJun 5, 2020Data Problem; Data Problem
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10123988 ↗InjuryMay 21, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
NEW INFORMATION NOTES THAT THE DEVICE WAS EXPLANTED AND REPLACED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10079498 ↗InjuryApr 14, 2020Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE DEVICE HAD REACH ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN ANTICIPATED. 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 9957697 ↗MalfunctionFeb 11, 2020Over-Sensing; Over-Sensing
DURING AN IN CLINIC FOLLOW-UP, THE DEVICE WAS INTERROGATED AND REVEALED EPISODES OF POST-PACED T-WAVE OVERSENSING (PPTWO). TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING TO RESOLVED THE EVENT. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9695338 ↗MalfunctionJan 28, 2020Over-Sensing; Over-Sensing
DURING AN IN-CLINIC FOLLOW UP, EPISODES OF T-WAVE OVERSENSING WERE NOTED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND 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 9638886 ↗DeathDec 26, 2019Under-Sensing; Under-Sensing
DURING VENTRICULAR FIBRILLATION, EPISODES OF UNDERSENSING WERE NOTED ON THE DEVICE WHICH WERE REPORTED BY THE PHYSICIAN TO HAVE INHIBITED THERAPY DELIVERY. THE PHYSICIAN REPORTED THE EVENT RESULTED IN PATIENT DEATH DUE TO CARDIAC ARREST. THE DEVICE REMAINS IMPLANTED AND INACTIVE.
Patient problems: Death
MAUDE report 9521785 ↗DeathDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO UNKNOWN CAUSES.
Patient problems: Death
MAUDE report 9511552 ↗InjuryJul 19, 2019Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate
DURING A SCHEDULED FOLLOW-UP, THE DEVICE COULD NO LONGER BE INTERROGATED DUE TO PREMATURE BATTERY DEPLETION. THE PATIENT RECEIVED MULTIPLE ALERTS REGARDING ERI, BUT NEGLECTED TO INFORM THE CLINIC. THE DEVICE WAS EXPLANTED AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8807700 ↗InjuryApr 29, 2019Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE DEVICE WAS NOT REPROGRAMMED TO DEACTIVATE HIGH VOLTAGE THERAPIES. DUE TO THE USE OF ELECTROCAUTERY, THE DEVICE OVERSENSED NOISE AND DELIVERED INAPPROPRIATE HIGH VOLTAGE THERAPY. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Therapeutic Effects, Unexpected
MAUDE report 8561209 ↗MalfunctionMar 26, 2019Failure to Deliver Shock/Stimulation; Energy Output Problem; Failure to Deliver Shock/Stimulation; Energy Output Problem
DURING A FOLLOW-UP IN CLINIC, LOW DEFIBRILLATION IMPEDANCE AND LOSS OF DEFIBRILLATION THERAPY WERE NOTED ON THE RIGHT VENTRICULAR LEAD. THE LEAD WAS CAPPED AND REPLACED AND THE PATIENT WAS STABLE WITH NO CONSEQUENCES. RELATED MANUFACTURER REPORT NUMBER: 2938836-2019-02112.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8453389 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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