FDA Adverse Event
Injury
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 4888454
·
Received June 30, 2015
Report
- Report Number
- 3008642652-2015-04157
- Event Type
- Injury
- Date Received
- June 30, 2015
- Date of Event
- June 23, 2015
- Report Date
- June 29, 2015
- Manufacturer
- ZOLL MANUFACTURING CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION METHOD: BIOCOMPATIBILITY TESTING TO ISO (B)(4) WAS SUCCESSFULLY COMPLETED ON SKIN-CONTACTING SURFACES OF THE LIFEVEST DEVICE AS WELL AS THE BLUE DEFIBRILLATION GE.
Description of Event or Problem · 1
A DISTRIBUTOR CONTACTED ZOLL ON (B)(6) TO REPORT THAT A (B)(6) YEAR OLD PT HAS OPEN WOUNDS THAT PREVENTED THE PT FROM WEARING THE LIFEVEST. THE PT REMOVED THE DEVICE AND THE PT'S PHYSICIAN WAS AWARE. THE PT USED AN ANTIBIOTIC CREAM TO TREAT THE WOUND. FOLLOW-UP INDICATED THAT THE PT'S WOUNDS WERE HEALING AND NO LONGER OPEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422287 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other| R |