FDA Adverse Event
Other
Summary report: N
PULSE GEN MODEL 102
MDR report key: 841898
·
Received April 18, 2007
Report
- Report Number
- 1644487-2007-00236
- Event Type
- Other
- Date Received
- April 18, 2007
- Date of Event
- February 1, 2007
- Report Date
- March 29, 2007
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO DEVICE MALFUNCTION SUSPECTED OR REPORTED IN CONJUNCTION WITH THE REPORTED DEATH.
Description of Event or Problem · 1
REPORTER INDICATED THAT THE PT EXPIRED FROM SLEEP APNEA AND THAT AN AUTOPSY WOULD NOT BE PERFORMED. IT WAS ALSO REPORTED THAT THE VNS DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. PATIENT'S TREATING PHYSICIAN REPORTED "PT FOUND IN THE AM, PASSED DURING SLEEP". PHYSICIAN REPORTED DEATH "NOT RELATED" TO VNS. NO AUTOPSY WILL BE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | LYJ | CYBERONICS, INC. | 102 | 014460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other |