FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1120811
·
Received August 15, 2008
Report
- Report Number
- 1644487-2008-01933
- Event Type
- Injury
- Date Received
- August 15, 2008
- Date of Event
- July 10, 2008
- Report Date
- July 17, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH OF GENERATOR AND LEAD PRIOR TO DISTRIBUTION.
Description of Event or Problem · 1
IT WAS REPORTED A VNS PATIENT PRESENTED WITH "AN OPEN INCISION ON HIS CHEST." THE PATIENT WAS TREATED WITH ANTIBIOTICS I.V. IN ADDITION TO THE ANTIBIOTICS, THE PATIENT UNDERWENT SURGERY TO RELOCATE THE GENERATOR. TWO CULTURES TAKEN PRIOR TO THE SURGERY YIELDED NEGATIVE RESULTS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | PULSE GENERATOR | LYJ | CYBERONICS, INC. | 102 | 200742 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Required Intervention |