FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2990919
·
Received March 6, 2013
Report
- Report Number
- 1644487-2013-00598
- Event Type
- Injury
- Date Received
- March 6, 2013
- Date of Event
- January 1, 2013
- Report Date
- February 5, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
ON (B)(6) 2013, IT WAS REPORTED THAT THIS VNS PATIENT PRESENTED TO HIS PHYSICIAN FOR THE SECOND TIME IN TWO WEEKS WITH BREAKTHROUGH SEIZURES. THE OUTPUT CURRENT AND DUTY CYCLE WERE INCREASED. THE PHYSICIAN FELT THE PATIENT'S DEVICE WAS NEARING END OF SERVICE DESPITE THE BLC RESULTS PREVIOUSLY PROVIDED. THE PATIENT WAS REFERRED FOR PROPHYLACTIC GENERATOR REVISION. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96136 | PULSE GEN MODEL 102 | GENERATOR | LYJ | CYBERONICS INC | 102 | 014788 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other |