FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 4100986
·
Received September 19, 2014
Report
- Report Number
- 1644487-2014-02383
- Event Type
- Malfunction
- Date Received
- September 19, 2014
- Date of Event
- August 21, 2014
- Report Date
- August 21, 2014
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014, THE VNS PATIENT¿S LEAD WAS INADVERTENTLY CUT DURING THE PROCEDURE. THE PATIENT¿S GENERATOR WAS EXPLANTED BUT THE REPLACEMENT GENERATOR WAS NOT IMPLANTED. THE LEAD WAS NOT EXPLANTED AND THE PROCEDURE WAS ABORTED. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584332 | LEAD MODEL 302 | LEAD | LYJ | CYBERONICS INC | 302-20 | 1368 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |