FDA Adverse Event
Death
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 1060305
·
Received June 12, 2008
Report
- Report Number
- 3002158293-2008-00258
- Event Type
- Death
- Date Received
- June 12, 2008
- Date of Event
- April 19, 2008
- Report Date
- April 11, 2008
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE MANUFACTURE DATE: MONITOR - 12/2007. ELECTRODE BELT - 05/2007. DEVICE EVALUATION SUMMARY: DEVICE EVALUATIONS OF MONITOR AND ELECTRODE BELT HAVE BEEN COMPLETED. BOTH THE MONITOR AND THE ELECTRODE BELT WERE FOUND TO BE FUNCTIONALLY NORMAL. THEY WERE RETESTED AND RESTOCKED.
Description of Event or Problem · 1
IN 2008, THE SISTER OF A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PT HAD PASSED AWAY WHILE IN THE HOSPITAL WEARING THE DEVICE. SHE STATED THAT BLUE GEL HAD DISPERSED FROM THE SYSTEM. TWO DAYS LATER, THE PATIENT'S SYSTEM WAS RECEIVED AT LIFECOR. THE SYSTEM SHOWED THREE APPROPRIATE SHOCKS FROM THE LIFEVEST THAT CONVERTED THE PT. THE DOWNLOAD ALSO SHOWED A TREATMENT THAT WAS DELIVERED FROM AN EXTERNAL SOURCE AND THEN AN APPROPRIATE ASYSTOLE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 3000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Death |