FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102R
MDR report key: 1120808
·
Received August 15, 2008
Report
- Report Number
- 1644487-2008-01893
- Event Type
- Injury
- Date Received
- August 15, 2008
- Date of Event
- January 1, 2008
- Report Date
- July 18, 2008
- 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 MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION AND HAD GENERATOR EXPLANTED. DEVICE STERILITY WAS CONFIRMED WITH MANUFACTURER. LOCATION OF INFECTION WAS AT THE GENERATOR SITE. CULTURES WERE TAKEN OF THE AREA AND A STAPH INFECTIONS WAS FOUND. PHYSICIAN REPORTS THAT PATIENT'S SKIN IS VERY THIN AND SKIN EROSION IS THE BELIEVED CAUSE OF INFECTION. PATIENT IS DOING WELL AND WILL HAVE GENERATOR REPLACED AT A LATER TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102R | LYJ | CYBERONICS, INC. | 102R | 016522 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |