Promote® RF (REF 3207-36)Recalls & 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
- 5
- Deaths reported
- 1
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734501958), received between Jun 27, 2018 and Jun 20, 2022 — classified as 1 death, 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Fracture1
- Naturally Worn1
- Signal Artifact/Noise1
Patient problems
- No Information2
- Death1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 20, 2022Naturally Worn; Naturally Worn
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-12904. IT WAS REPORTED THAT DURING ROUTINE GENERATOR EXCHANGE THAT DEVICE INTERROGATION REVEALED CAUSED BY EXTERNALIZED CONDUCTORS DAMAGE VISUALLY FOUND ON THE RIGHT VENTRICULAR (RV). ON FURTHER INTERROGATION IT SHOWED HIGH CAPTURE THRESHOLDS ON THE LEFT VENTRICLE (LV) LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RV AND LV LEAD. THE PATIENT WAS IN STABLE CONDITION BEFORE, DURING, AND AFTERWARDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14744059 ↗InjuryOct 19, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS DEFECTIVE. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2013.
Patient problems: No Information
MAUDE report 10701907 ↗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 8104097 ↗MalfunctionJun 27, 2018Signal Artifact/Noise; Break; Fracture; Signal Artifact/Noise; Break; Fracture
IT WAS NOTED THAT THE PATIENT PRESENTED FOR FOLLOW-UP ON (B)(6) 2009, THE PATIENT HAD EXPERIENCED A SENSATION OF PALPITATIONS WITH EXERTION BUT AT THE TIME, DIAPHRAGMATIC STIMULATION COULD NOT BE ELICITED. THE DEVICE WAS REPROGRAMMED AND THE SYMPTOMS SEEMED TO HAVE BEEN RESOLVED. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR LEAD REVISION AND DEVICE CHANGE OUT PROCEDURE ON (B)(6) 2016. THE LEFT VENTRICULAR LEAD EXHIBITED DIAPHRAGMATIC STIMULATION DESPITE HAVING A HISTORY OF REPROGRAMMING AND THE RIGHT ATRIAL LEAD EXHIBITED NOISE. BOTH LEADS WERE EXPLANTED AND REPLACED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7644187 ↗DeathJun 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Death
MAUDE report 7642945 ↗
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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