FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 4152592
·
Received October 8, 2014
Report
- Report Number
- 1644487-2014-02588
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 8, 2014
- Report Date
- September 8, 2014
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE EXPLANTED GENERATOR AND LEAD WERE DISCARDED; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED.
Description of Event or Problem · 1
DURING GENERATOR REPLACEMENT, THE SURGEON OBSERVED THAT THE LEAD WAS STRETCHED AND WAS ALSO REPLACED. IT WAS REPORTED THAT THE LEAD WAS NOT WHAT THE SURGEON CONSIDERED AS GOOD QUALITY AND WAS OLD; THEREFORE, WAS REPLACED. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE EXPLANTED LEAD HAS NOT BEEN RECEIVED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632315 | BIPOL LEAD MODEL 300 | LEAD | LYJ | CYBERONICS, INC. | 300-20 | 7268C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |