FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2180726
·
Received July 22, 2011
Report
- Report Number
- 1644487-2011-01634
- Event Type
- Death
- Date Received
- July 22, 2011
- Date of Event
- March 8, 2009
- Report Date
- June 23, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANAYLSIS OF PROGRAMMING HISTORY/DEVICE DIANGOSTIC HISTORY AND BATTERY LIFE CALCULATION PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED BY A PHYSICIAN'S OFFICE THAT THE PT HAD PASSED AWAY ON (B)(6) 2009. THE PT'S LAST KNOWN SETTINGS WERE ON (B)(6) 2007. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE PATIENT WAS MOST LIKELY BURIED WITH THE VNS STILL IMPLANTED AS THERE ARE NO RECORDS OF THE DEVICE BEING EXPLANTED PRIOR TO BURIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 101 | 8719 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Death |