FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 2052550
·
Received April 11, 2011
Report
- Report Number
- 1644487-2011-00764
- Event Type
- Injury
- Date Received
- April 11, 2011
- Date of Event
- February 1, 2011
- Report Date
- March 15, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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
RPTR INDICATED A PT DEVELOPED AN INFECTION AT THE VNS GENERATOR SITE DUE TO VOMITUS ENTERING THE WOUND. THE VNS GENERATOR WAS LATER EXPLANTED. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 103 | LYJ | CYBERONICS, INC. | 103 | 201586 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Required Intervention |