FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1196875
·
Received October 8, 2008
Report
- Report Number
- 1644487-2008-02444
- Event Type
- Malfunction
- Date Received
- October 8, 2008
- Date of Event
- September 2, 2008
- Report Date
- September 9, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. REVIEW OF X-RAYS REVEALED LEAD CONNECTOR PIN WAS NOT FULLY INSERTED INTO GENERATOR CONNECTOR BLOCK.
Description of Event or Problem · 1
REPORTER INDICATED THAT FOLLOWING GENERATOR REPLACEMENT SURGERY, THE PATIENT'S DEVICE SHOWED HIGH LEAD IMPEDANCE. PER REPORTER, THERE WAS NO CHANGE IN SEIZURE PATTERN. UPON REVIEW OF X-RAYS, IT WAS NOTED THAT THE LEAD CONNECTOR PIN WAS NOT FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. PER REPORTER, SURGERY TO FIX THE CONNECTOR PIN IS PLANNED. ALL ATTEMPTS FOR FURTHER INFO ARE PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 20786 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |