FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1241171
·
Received November 20, 2008
Report
- Report Number
- 1644487-2008-02826
- Event Type
- Injury
- Date Received
- November 20, 2008
- Date of Event
- July 23, 2008
- Report Date
- October 24, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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 VNS PT THAT WAS IMPLANTED IN 2008, HAS AN INFECTION AT THE LEAD AND GENERATOR INCISION SITES. THE PT IS CURRENTLY ON ORAL ANTIBIOTICS AND MAY HAVE THE VNS EXPLANTED. ATTEMPTS FOR FURTHER INFO FROM THE RPTR HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 200752 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |