FDA Adverse Event
Malfunction
Summary report: N
PROMOTE ACCEL CRT-D
MDR report key: 2243078
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06578
- Event Type
- Malfunction
- Date Received
- September 11, 2011
- Date of Event
- July 20, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- 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 DEVICE COULD NOT BE INTERROGATED DUE TO SEVERAL EXTERNAL DEFIBRILLATIONS. THE DEVICE WAS FOUND IN RESET MODE. THE DEVICE WAS PROGRAMMED OFF VIA ETP PROGRAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 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 | 62 YR |