FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1191923
·
Received October 1, 2008
Report
- Report Number
- 1644487-2008-02367
- Event Type
- Malfunction
- Date Received
- October 1, 2008
- Date of Event
- March 19, 2008
- Report Date
- July 31, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DIAGNOSTICS PERFORMED PRIOR TO A VNS PT'S REVISION SURGERY RESULTED IN HIGH LEAD IMPEDANCE. THE REPORTER INDICATED THAT THE SURGEON HAD DECIDED TO REPLACE THE PT'S LEAD BECAUSE THERE WAS A SIGNIFICANT AMOUNT OF SCAR TISSUE AT THE ELECTRODE SITE WHICH HE BELIEVED WOULD CONTINUE TO CONTRIBUTE TO THE HIGH IMPEDANCE. THE EXPLANTED PRODUCTS WERE DISCARDED BY THE HOSP. GOOD FAITH ATTEMPTS FOR ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 010220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |