FDA Adverse Event
Injury
Summary report: N
LEAD MODEL 304
MDR report key: 3982283
·
Received August 5, 2014
Report
- Report Number
- 1644487-2014-01946
- Event Type
- Injury
- Date Received
- August 5, 2014
- Date of Event
- June 16, 2014
- Report Date
- July 11, 2014
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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 THE RECENTLY IMPLANTED VNS PATIENT DEVELOPED AN INFECTION AT HER NECK INCISION SITE. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2014 TO EXPLANT HER GENERATOR AND LEAD. THE PATIENT HAS NOT BEEN RE-IMPLANTED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 456472 | LEAD MODEL 304 | LEAD | LYJ | CYBERONICS INC | 304-20 | 202885 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Required Intervention |