FDA Adverse Event
Malfunction
Summary report: N
PROMOTE PLUS CRT-D
MDR report key: 2902581
·
Received January 8, 2013
Report
- Report Number
- 2017865-2013-00428
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- November 30, 2012
- 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
THE REPORTED BVVI MODE AND NO COMMUNICATION WERE CONFIRMED IN THE LABORATORY AND WAS DUE TO A POWER ON RESET. THE DEVICE WAS TESTED ON THE BENCH AND HIGH CURRENT DRAINS WERE OBSERVED. DURING TESTING, THE CURRENT RETURNED TO NORMAL AND THE DEVICE BEHAVED NORMALLY. THE ROOT CAUSE OF THE POWER ON RESET COULD NOT BE DETERMINED.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS IN BVVI MODE. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9482 | PROMOTE PLUS CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3211-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |