FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102R
MDR report key: 1212584
·
Received October 24, 2008
Report
- Report Number
- 1644487-2008-02559
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 26, 2008
- 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 REPORTED THAT THE VNS PATIENT HAS BEEN EXPERIENCING SEVERE DYSPNEA DURING STIMULATION. THE PHYSICIAN TRIED DIFFERENT SETTINGS TO HELP ALLEVIATE PATIENT'S DYSPNEA BUT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO TURN THE DEVICE OFF BY PROGRAMMING THE OUTPUT CURRENT TO 0MA. DEVICE DISABLEMENT WAS INTENDED TO BE PERMANENT AS OF 2008. THE PATIENT'S MEDICATION WAS CHANGED TO HELP WITH THE SEIZURES INSTEAD OF VNS THERAPY. NO MALFUNCTION WITH THE DEVICE IS SUSPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102R | LYJ | CYBERONICS, INC. | 102R | 012991 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |