FDA Adverse Event
Injury
Summary report: N
PROMOTE ACCEL CRT-D
MDR report key: 3220155
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04523
- Event Type
- Injury
- Date Received
- July 11, 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. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF BACKUP VVI MODE WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A POWER ON RESET. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND NO ANOMALIES WERE FOUND. THE CAUSE OF THE POWER ON RESET REMAINS UNDETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP, IT WAS OBSERVED THAT THE DEVICE WAS IN BACKUP VVI. THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321068 | 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 | Required Intervention |