FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2190921
·
Received July 29, 2011
Report
- Report Number
- 1644487-2011-01704
- Event Type
- Injury
- Date Received
- July 29, 2011
- Date of Event
- June 16, 2011
- Report Date
- June 30, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MFG RECORDS WERE REVIEWED. REVIEW OF MFG RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.
Description of Event or Problem · 1
IT WAS REPORTED BY A PHYSICIAN'S OFFICE THAT THE PT DEVELOPED A "SEVERE STAPH INFECTION" AROUND THE GENERATOR. THE DEVICE HAD TO BE REMOVED, AND THE PT SATED HE DID NOT WANT IT REPLACED. A REVIEW OF THE PT'S LEAD AND GENERATOR'S DESIGN HISTORY RECORDS SHOWED THEY WERE BOTH PROPERLY STERILIZED BEFORE SHIPPING. THE PT'S PHYSICIAN STATED ADDITIONAL INFO WAS UNKNOWN TO THEM AS THE PT WAS FOLLOWED IN HIS HOME-TOWN BY AN UNK DOCTOR. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 011252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |