Promote® 3107-36Recalls & reported problems
St. Jude Medical, Inc. · Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV · Class 3 · Implant
All models of Promote (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734502221), received between Jun 16, 2018 and Jun 28, 2019 — classified as 4 injuries.
The most frequently reported specific device problem is “Premature Discharge of Battery” (4 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 Battery4
- Data Problem1
- Inappropriate/Inadequate Shock/Stimulation1
- Incorrect Interpretation of Signal1
Patient problems
- No Known Impact Or Consequence To Patient3
- Therapeutic Effects, Unexpected1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2019Premature 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 THE PATIENT RECEIVED INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR. THE DEVICE ALSO EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: Therapeutic Effects, Unexpected
MAUDE report 8745732 ↗InjuryNov 21, 2018Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE DEVICE REACHED ERI PREMATURELY. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8097740 ↗InjuryAug 21, 2018Premature Discharge of Battery; Data Problem; Premature Discharge of Battery; Data Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS NOTED THAT THE BATTERY OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS DEPLETED AND GARBLED CODE WAS DISPLAYED ON THE PROGRAMMER. THE PREMATURE BATTERY DEPLETION WAS SUSPECTED TO HAVE BEEN CAUSED BY HIGH OUTPUT SETTINGS DUE TO PATIENT'S HEALTH CONDITION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE POST-PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7803176 ↗InjuryJun 16, 2018Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT DURING ROUTINE FOLLOW-UP IN CLINIC, DEVICE WAS FOUND TO REACH ERI AND PREMATURE BATTERY DEPLETION WAS NOTED. DEVICE WAS EXPLANTED AND REPLACED. PATIENT¿S CONDITION WAS STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7608341 ↗
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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