FDA Adverse Event
Malfunction
Summary report: N
CURRENT PLUS DR, DF4 CONNECTOR
MDR report key: 2950140
·
Received February 8, 2013
Report
- Report Number
- 2938836-2013-00064
- Event Type
- Malfunction
- Date Received
- February 8, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- 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 DEVICE RESET CONDITION WAS NOT CONFIRMED IN THE LABORATORY. AS RECEIVED, THE DEVICE WAS NOT FOUND TO BE IN THE RESET MODE. THE DEVICE TESTED NORMALLY AND ALL SPECIFICATIONS WERE MET. THE CAUSE OF THE REPORTED RESET CONDITION WAS NOT DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS FOUND IN BVVI MODE AFTER AN EXTERNAL MAGNET WAS PLACED ON THE DEVICE FOR 24 HOURS. THE THERAPY WAS DISABLE DUE TO PATIENT WAS IN PALLIATIVE CARE. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54739 | CURRENT PLUS DR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |