FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102
MDR report key: 4933194
·
Received July 22, 2015
Report
- Report Number
- 1644487-2015-05291
- Event Type
- Death
- Date Received
- July 22, 2015
- Date of Event
- November 15, 2013
- Report Date
- June 25, 2015
- Manufacturer
- CYBERONICS INC
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2013 DUE TO INHALATION AND INGESTION OF FOOD CAUSING OBSTRUCTION OF RESPIRATORY TRACT. PATIENT ALSO HAD DEMENTIA AND CHRONIC ISCHEMIC HEART DISEASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 475791 | PULSE GEN MODEL 102 | GENERATOR | MUZ | CYBERONICS INC | 102 | 013118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Death |