FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102R
MDR report key: 3643590
·
Received February 24, 2014
Report
- Report Number
- 1644487-2014-00519
- Event Type
- Injury
- Date Received
- February 24, 2014
- Date of Event
- January 9, 2014
- Report Date
- January 27, 2014
- Manufacturer
- CYBERONICS INC
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A HEART ATTACK A FEW WEEKS BACK. IT WAS REPORTED THAT THE PATIENT IS NOW RECOVERED. THE CARDIOLOGIST WAS UNSURE OF THE RELATIONSHIP BETWEEN VNS THERAPY AND THE HEART ATTACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 113013 | PULSE GEN MODEL 102R | GENERATOR | MUZ | CYBERONICS INC | 102R | 013834 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Hospitalization |