FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1031591
·
Received March 18, 2008
Report
- Report Number
- 1644487-2008-00710
- Event Type
- Injury
- Date Received
- March 18, 2008
- Date of Event
- February 18, 2008
- Report Date
- February 18, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT A VNS PATIENT'S GENERATOR HAD MIGRATED, AND THE PATIENT WAS EXPERIENCING A "TINGLING SENSATION" UNDER HER LEFT ARM. NO TRAUMA OR PATIENT MANIPULATION WAS REPORTED. THE PATIENT HAD LOST A LOT OF WEIGHT. GENERATOR POCKET REVISION SURGERY IS PLANNED. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | MUZ | CYBERONICS, INC. | 102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |