FDA Adverse Event
Malfunction
Summary report: N
MICRO VENTRICULAR BOLT
MDR report key: 525587
·
Received February 20, 2004
Report
- Report Number
- 2023988-2004-00017
- Event Type
- Malfunction
- Date Received
- February 20, 2004
- Report Date
- February 17, 2004
- Manufacturer
- INTEGRA NEUROCARE LLC
- Product Code
- GWM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
OVER THE PAST COUPLE OF MONTHS THE BOLTS ARE BECOMING LOOSE AFTER PLACEMENT. UNK HOW MANY PTS WERE INVOLVED. IN SOME CASES THEY HAD TO REPLACE THE ENTIRE BOLT. AT FIRST THEY WERE UNSURE IF THIS WAS DUE TO PT MOVEMENT BUT THIS WAS OCCURRING MORE THAN USUAL, APPROXIMATELY 4 TO 5 TIMES. THESE OCCURRENCES WERE REPORTED WITH THE DEVICE BEING IN PLACE FOR A FEW DAYS. THIS ACCOUNT AT TIMES CAN PLACE 6 DEVICES IN ONE WEEK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO VENTRICULAR BOLT | NEURO MONITORING | GWM | INTEGRA NEUROCARE LLC | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |