FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1243692
·
Received November 25, 2008
Report
- Report Number
- 1644487-2008-02862
- Event Type
- Injury
- Date Received
- November 25, 2008
- Date of Event
- October 8, 2008
- Report Date
- November 3, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PT EXPERIENCED A MILD INFECTION AT THE INCISION SITE IN THE LEFT ARM PIT. THE INFECTION WAS A RESULT OF VNS IMPLANT SURGERY. MEDICATION (KEPLEX) WAS ADDED, AND THE INFECTION RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | MUZ | CYBERONICS, INC. | 102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Required Intervention |