FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2880402
·
Received December 19, 2012
Report
- Report Number
- 1644487-2012-03405
- Event Type
- Injury
- Date Received
- December 19, 2012
- Date of Event
- March 1, 2012
- Report Date
- November 19, 2012
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THE PATIENT HAD A MANIC EPISODE (B)(6) 2012. THE MONTH BEFORE THE PATIENT HAD THEIR SETTINGS INCREASED. THE PHYSICIAN FELT THAT THE INCREASE IN SETTINGS MAY HAVE BEEN A TRIGGER FOR THE MANIC EPISODE. THE PATIENT WAS REFERRED TO A PSYCHIATRIST AND HAD THEIR SETTING LOWERED. SINCE THEN THE SETTINGS HAVE BEEN ADJUSTED BUT THE PATIENT HAS BEEN DOING WELL WITH NO ADDITION BOUTS OF MANIA. NO FURTHER INFORMATION WAS PROVIDED BY THE PHYSICIAN'S OFFICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | GENERATOR | LYJ | CYBERONICS INC | 102 | 016250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |