FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1253135
·
Received December 5, 2008
Report
- Report Number
- 1644487-2008-02937
- Event Type
- Injury
- Date Received
- December 5, 2008
- Date of Event
- October 17, 2008
- Report Date
- November 13, 2008
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THAT THE PT HAD THEIR VNS SYSTEM EXPLANTED RELATED TO "INTOLERANCE TO VNS". THE EXPLANTED PRODUCT IS AT MANUFACTURER. ANALYSIS IS COMPLETED ON THE LEAD. THE GENERATOR ANALYSIS IS PENDING COMPLETION. THE LEAD WAS RETURNED WITHOUT THE ELECTRODE ARRAY, SO AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS NO ADVERSE FINDINGS WERE IDENTIFIED IN THE RETURNED LEAD PORTION. GOOD FAITH ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL DETAILS ABOUT THE REASON FOR EXPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS INC | 102 | 014675 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization| R |