FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1033377
·
Received April 23, 2008
Report
- Report Number
- 1644487-2008-00997
- Event Type
- Injury
- Date Received
- April 23, 2008
- Date of Event
- March 5, 2008
- Report Date
- March 25, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
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 THAT A VNS PT DEVELOPED AN INFECTION AT THE LEAD AND GENERATOR INCISION SITES EIGHT DAYS POST VNS IMPLANT SURGERY. PUS WAS NOTED AT THE NECK INCISION AND THE CHEST INCISION HAD A NON-HEALING CENTER. CULTURES OF THE NECK INCISION GREW OUT STAPHYLOCOCCUS AUREUS. THE CHEST INCISION SUTURES WERE REMOVED. THE PT UNDERWENT "WASHOUT" OF THE INCISIONS UNDER GENERAL ANESTHESIA AND HAD A COURSE OF ANTIBIOTICS. NO VNS PRODS HAVE BEEN EXPLANTED. GOOD FAITH ATTEMPTS ARE IN PROGRESS REGARDING THE CAUSE OF THE INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 200629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |