FDA Adverse Event
Death
Summary report: N
PROMOTE ACCEL CRT-D
MDR report key: 3210535
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03421
- Event Type
- Death
- Date Received
- July 8, 2013
- Date of Event
- April 22, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT REVIEWED MULTIPLE SHOCKS FROM THE ICD AND EXTERNAL DEFIBRILLATOR DUE TO PERSISTENT VT. THE DEVICE WAS LATER FOUND IN BACKUP VVI MODE. ATTEMPTS TO RESTORE THE DEVICE FAILED DUE TO LOSS OF COMMUNICATION WITH THE DEVICE. IT WAS LATER REPORTED THAT THE PATIENT EXPIRED DUE TO HEART FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311372 | PROMOTE ACCEL CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3215-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Death |