FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 105
MDR report key: 6085301
·
Received November 8, 2016
Report
- Report Number
- 1644487-2016-02587
- Event Type
- Death
- Date Received
- November 8, 2016
- Date of Event
- September 20, 2016
- Report Date
- October 14, 2016
- Manufacturer
- CYBERONICS - HOUSTON
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A VNS PATIENT HAD REPORTEDLY PASSED AWAY. THE PATIENT'S PHYSICIAN SUSPECTED THE DEATH WAS SUDEP BUT NO AUTOPSY WAS PERFORMED. THE PATIENT'S VNS DEVICE HAD BEEN DISABLED THE DAY AFTER THE PATIENT UNDERWENT REPLACEMENT. THERE WAS NO NOTE OF THE PATIENT'S DEVICE BEING PROGRAMMED BACK ON. A REVIEW OF THE AVAILABLE PROGRAMMING HISTORY SHOWED THAT THE PATIENT'S DEVICE HAD BEEN OPERATING AS INTENDED AFTER IMPLANT ON (B)(6) 2016. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 735730 | PULSE GEN MODEL 105 | GENERATOR | LYJ | CYBERONICS - HOUSTON | 105 | 203343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Death |