FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL UNKNOWN
MDR report key: 1843802
·
Received September 22, 2010
Report
- Report Number
- 1644487-2010-02152
- Event Type
- Injury
- Date Received
- September 22, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 23, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S GENERATOR ROTATES UP WHEN THE PATIENT TURNS HER SHOULDER A CERTAIN WAY. DIAGNOSTICS ARE ALL OKAY AND THE PATIENT FEELS STIMULATION LIKE NORMAL. THE PATIENT'S SEIZURES ARE WELL-CONTROLLED, BUT THE PATIENT WOULD LIKE TO MEET WITH A SURGEON TO POSSIBLY PLACE THE GENERATOR IN A DIFFERENT LOCATION, UNDER THE MUSCLE, TO KEEP IT FROM ROTATING WHEN SHE MOVES HER ARM. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL UNKNOWN | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other |