FDA Adverse Event
Malfunction
Summary report: N
SUBDURAL CATHETER
MDR report key: 719391
·
Received May 24, 2006
Report
- Report Number
- 9612007-2006-00021
- Event Type
- Malfunction
- Date Received
- May 24, 2006
- Report Date
- May 22, 2006
- Manufacturer
- INTEGRA NEUROSCIENCES IMPLANTS S.A.
- Product Code
- GWM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER FOUND THE LOCATOR WAS MISSED WHEN THEY PULLED THE SUBDURAL CATHETER OUT FROM THE PATIENT'S BRAIN AFTER SURGICAL PROCEDURE. THEY USED A NEW SUBDURAL CATHETER AND FOUND THE LOCATOR WAS EASY TO PULL OUT FROM THE SUBDURAL CATHETER. THE HOSPITAL FURTHER STATES THAT SINCE THE LOCATOR IS MADE FROM A PLASTIC METAL, THERE IS NO WAY TO CHECK IF IT IS STILL IN THE BRAIN OR HAS BEEN EJECTED OUTSIDE THE BRAIN WHEN THE CATHETER WAS PULLED OUT. TECHNICAL SERVICE IDENTIFIED THE PRODUCT ID AS 951315, BUT WAS UNABLE TO IDENTIFY THE LOT NUMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUBDURAL CATHETER | ICP MONITORING | GWM | INTEGRA NEUROSCIENCES IMPLANTS S.A. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |