BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO VENTRICULAR BOLT

    MDR report key: 69702 · Received February 14, 1997

    Report

    Report Number
    2023988-1997-00001
    Event Type
    Injury
    Date Received
    February 14, 1997
    Report Date
    January 16, 1997
    Manufacturer
    CAMINO NEUROCARE, INC.
    Product Code
    GWM
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WHILE THE DOCTOR WAS TIGHTENING THE COMPRESSION CAP, THEN WITHDRAWING THE CATHETER A LITTLE, THE DISTAL VENTRICULAR PIECE DETACHED FROM THE PROXIMAL AND REMAINED IN THE PT'S HEAD. THE DOCTOR REMOVED THE PIECE FROM THE HEAD WITHOUT CAUSING INJURY TO THE PT. A NEW CATHETER WAS PLACED AND EVERYTHING WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO VENTRICULAR BOLT Implant ICP PRESSURE MONITORING DEVICE GWM CAMINO NEUROCARE, INC. 110-4HM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN