FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 105
MDR report key: 2181386
·
Received July 21, 2011
Report
- Report Number
- 1644487-2011-01654
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- April 18, 2011
- Report Date
- June 21, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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 THAT THE PT'S CARETAKER HAS NOTICED SOME REDNESS AROUND THE INCISION SITE. AFTER HER LAST OFFICE VISIT ON (B)(6), 2011, SHE WAS ADMITTED TO THE HOSPITAL FOR CELLULITIS RELATED TO HER RECENT VAGAL NERVE STIMULATOR IMPLANTATION. THE INCISION SITE OF HER VAGAL NERVE STIMULATOR WAS ERYTHEMATOUS. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 105 | LYJ | CYBERONICS, INC. | 105 | 2871 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Hospitalization| L |