FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 103
MDR report key: 2170038
·
Received July 15, 2011
Report
- Report Number
- 1644487-2011-01601
- Event Type
- Death
- Date Received
- July 15, 2011
- Date of Event
- June 21, 2011
- Report Date
- June 21, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A NURSE THAT A VNS PT WAS DECEASED. THE NURSE DID NOT PROVIDE ADD'L INFO AT THE TIME OF INITIAL REPORT AND THE RELATIONSHIP OF VNS THERAPY TO THE PT'S DEATH REMAINS UNK. THE PT WAS EXPLANTED OF VNS THERAPY PRIOR TO BURIAL AND THE EXPLANTED DEVICES REMAIN IN TRANSIT TO BE RETURNED TO THE MFR. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 103 | LYJ | CYBERONICS, INC. | 103 | 16639 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Death |