FDA Adverse Event
Malfunction
Summary report: N
EPILEPSY 64 GRID
MDR report key: 886447
·
Received October 20, 2004
Report
- Report Number
- 9612007-2004-00050
- Event Type
- Malfunction
- Date Received
- October 20, 2004
- Report Date
- October 20, 2004
- Manufacturer
- INTEGRA NEUROSCIENCES IMPLANTS S.A.
- Product Code
- GYC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT EXPECTED TO BE RETURNED. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
THE CUSTOMER HAS BEEN HAVING TROUBLE WITH INTEGRA'S 64 GRID (PART # 17194-8), MOST RECENTLY IN 2004. WHEN THE CUSTOMER CONNECTS THE PIG TAIL INTO THE CONNECTOR, THE SIGNAL IS WEAK OR NO SIGNAL WAS DETECTED AT ALL. WHEN A SIGNAL IS ACHIEVED, IT IS NOT VERY CLEAR COMPARED TO THE COMPETITOR AD-TECH PROD. ADD'L INFO WAS REC'D ON OCTOBER 6, 2004. THE PROBLEMS WERE N THE CONNECTIONS. THE LEADS DID NOT FIT INTO THE RECEPTACLE EASILY. THE RECORDINGS WERE UNINTERPRETABLE. ALL PROBLEMS WENT AWAY WHEN THE CUSTOMER REMOVED INTEGRA'S GRIDS AND REPLACED WITH COMPETITOR'S PROD. A RETURN IS NOT EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPILEPSY 64 GRID | EPILEPSY PRODUCT | GYC | INTEGRA NEUROSCIENCES IMPLANTS S.A. | * | 0137541 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |