FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2466201
·
Received February 23, 2012
Report
- Report Number
- 1644487-2012-00503
- Event Type
- Injury
- Date Received
- February 23, 2012
- Date of Event
- September 29, 2011
- Report Date
- January 27, 2012
- Manufacturer
- CYBERONICS INC
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA AN "ASSESSMENT OF SUICIDALITY" FORM THAT THE PATIENT HAD RECENTLY EXPERIENCED TWO SUICIDAL GESTURES THAT WERE DESCRIBED AS "DEFINITE BUT VERY AMBIVALENT" AND "NO DANGER TO LIFE." IT WAS INDICATED THAT THERE WAS NO RELATIONSHIP TO THE PATIENT'S MEDICATION AND A PROBABLE RELATIONSHIP TO THE PATIENT'S MENTAL DISORDER. THE RELATIONSHIP OF THE SUICIDAL GESTURES TO VNS IS CURRENTLY UNKNOWN. 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 | GENERATOR | MUZ | CYBERONICS INC | 102 | 200670 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Life Threatening |