FDA Adverse Event
Malfunction
Summary report: N
MICRO VENT. BOLT 110-4HMT
MDR report key: 1022729
·
Received March 27, 2008
Report
- Report Number
- 2023988-2008-00015
- Event Type
- Malfunction
- Date Received
- March 27, 2008
- Date of Event
- March 17, 2008
- Report Date
- March 27, 2008
- Manufacturer
- INTEGRA NEURO SCIENCES
- Product Code
- GWM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
THE REPORTER STATED THAT WHEN THE CATHETER WAS IMPLANTED, IT WAS NOT READING INTERCRANIAL PRESSURE CORRECTLY. A READING WAS NOT OBTAINED. IT IS THOUGHT THAT THE CATHETER WAS IMPLANTED CORRECTLY BECAUSE CEREBROSPINAL FLUID DRAINED FROM THE CATHETER. ON REMOVAL OF THE CATHETER, THE WHITE PLASTIC PART OF THE CATHETER TIP BROKE OFF AT THE BASE OF THE BOLT. THE SURGEON DRILLED A LARGER HOLE IN THE SKULL TO REMOVE THE BROKEN PIECE OF CATHETER FROM THE BRAIN. THIS PROCEDURE WAS SUCCESSFUL WITH NO APPARENT RELATED INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO VENT. BOLT 110-4HMT | CAMINO CATHETER WITH DRAIN | GWM | INTEGRA NEURO SCIENCES | 110-4HMT | 305000097842 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |