FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 3243456
·
Received July 23, 2013
Report
- Report Number
- 1644487-2013-02210
- Event Type
- Injury
- Date Received
- July 23, 2013
- Date of Event
- January 1, 2012
- Report Date
- June 25, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2013, IT WAS REPORTED THAT THIS VNS PATIENT¿S DEVICE WAS DISABLED IN EARLY 2012 DUE TO CONCERNS FOR BRADYCARDIA. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343824 | PULSE GEN MODEL 102 | GENERATOR | LYJ | CYBERONICS INC | 102 | 015950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |