FDA Adverse Event
Injury
Summary report: N
LEAD MODEL 302
MDR report key: 1120737
·
Received August 15, 2008
Report
- Report Number
- 1644487-2008-01916
- Event Type
- Injury
- Date Received
- August 15, 2008
- Date of Event
- June 1, 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
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED.
Description of Event or Problem · 1
REPORTER INDICATED THAT AFTER A VNS PATIENT RECEIVED CARDIAC DEFIBRILLATION AT HOME, SHE DEVELOPED STABBING, INTERMITTENT NECK PAIN. DEVICE DIAGNOSTICS WERE NORMAL. THE VNS WAS DISABLED AND THE PATIENT WAS SENT FOR A SURGICAL CONSULT. X-RAY REVIEW BY THE MANUFACTURER DID NOT REVEAL ANY LEAD ANOMALIES. THE PATIENT LATER UNDERWENT VNS LEAD AND GENERATOR REVISION SURGERY. THE EXPLANTED DEVICES HAVE BEEN RETURNED AND ARE CURRENTLY IN PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 1080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |