FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 1248023
·
Received December 1, 2008
Report
- Report Number
- 1644487-2008-02863
- Event Type
- Injury
- Date Received
- December 1, 2008
- Date of Event
- November 1, 2008
- Report Date
- November 10, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT A VNS PT WAS HOSPITALIZED DUE TO KIDNEY PROBLEMS. DURING THIS HOSPITALIZATION, THE HOSP PHYSICIAN NOTED THAT THE PT WAS EXPERIENCING BRADYCARDIA. FURTHER FOLLOW UP REVEALED THAT THE PT WAS TO UNDERGO SURGERY FOR A PACEMAKER. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL. THE RELATIONSHIP BETWEEN THE BRADYCARDIA EVENT AND THE VNS THERAPY IS UNK AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL UNK | MUZ | CYBERONICS, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Life Threatening |