FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 2083010
·
Received May 4, 2011
Report
- Report Number
- 1644487-2011-00993
- Event Type
- Injury
- Date Received
- May 4, 2011
- Date of Event
- April 4, 2011
- Report Date
- April 4, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METHOD: DEVICE MANUFACTURING RECORDS WERE REVIEWED. RESULTS: 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 THE PT HAD HER VNS EXPLANTED DUE TO AN INFECTION. EXPLANTED PRODUCTS WERE RETURNED TO THE MANUFACTURER, BUT ANALYSIS IS PENDING. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 103 | LYJ | CYBERONICS, INC. | 103 | 2749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Life Threatening| R |