FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2063788
·
Received April 15, 2011
Report
- Report Number
- 1644487-2011-00817
- Event Type
- Injury
- Date Received
- April 15, 2011
- Date of Event
- January 1, 2011
- Report Date
- March 18, 2011
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THE PATIENT WAS TO UNDERGO VNS REPLACEMENT SURGERY AS SHE WAS NO LONGER FEELING STIMULATION. FOLLOW-UP WITH THE PHYSICIAN REVEALED THAT THE GENERATOR WAS BEING REPLACED PROPHYLACTICALLY AS THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURE ACTIVITY AND NO LONGER FELT STIMULATION OR HAD VOICE CHANGES. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO CAUSAL OR CONTRIBUTORY PROGRAMMING OR MEDICATION CHANGES PRECEDED THE ONSET OF THE EVENT. THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2011. ATTEMPTS FOR FURTHER INFORMATION AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS INC | 102 | 011454 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |