FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 101
MDR report key: 3942194
·
Received July 17, 2014
Report
- Report Number
- 1644487-2014-01821
- Event Type
- Death
- Date Received
- July 17, 2014
- Date of Event
- March 25, 2006
- Report Date
- June 24, 2014
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY ON (B)(6) 2006. NO OTHER INFORMATION WAS PROVIDED. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY SHOWED NORMAL DIAGNOSTIC RESULTS THROUGH (B)(6) 2006. BASED ON THE LIMITED AVAILABLE INFORMATION ABOUT THE PATIENT¿S DEATH, AN INTERNAL CLASSIFICATION HAS DETERMINED THAT THE DEATH MAY BE POSSIBLE SUDEP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 419101 | PULSE GEN MODEL 101 | GENERATOR | LYJ | CYBERONICS INC | 101 | 5131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Death |