FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 4151268
·
Received October 8, 2014
Report
- Report Number
- 1644487-2014-02576
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 11, 2014
- Report Date
- September 11, 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
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO END OF SERVICE, THE VNS PATIENT¿S LEAD REPORTEDLY SNAPPED WHEN CONNECTED TO THE REPLACEMENT GENERATOR. THE PATIENT¿S LEAD WAS ALSO REPLACED DURING THE PROCEDURE. THE PHYSICIAN STATED THAT THE PATIENT¿S LEAD WAS WEAKENED WHICH CAUSED THE BREAK. THE EXPLANTING FACILITY DISCARDED THE EXPLANTED DEVICE; THEREFORE, NO ANALYSIS CAN BE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632547 | BIPOL LEAD MODEL 300 | LEAD | LYJ | CYBERONICS INC | 300-20 | 17789C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |