BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPT BOLT

    MDR report key: 203548 · Received December 18, 1998

    Report

    Report Number
    203548
    Event Type
    Injury
    Date Received
    December 18, 1998
    Date of Event
    December 16, 1998
    Report Date
    December 18, 1998
    Manufacturer
    NEURO CARE, INC.
    Product Code
    GWM
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN PHYSICIAN REMOVED THE CPI BOLT THE RUBBER END OF THE CPI BOLT BROKE AND REMAINED IN THE RIGHT FRONTAL AREA. PT TO SURGERY FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPT BOLT Implant MICRO VENTRICULAR BOLT PRESSURE MONITORING KIT GWM NEURO CARE, INC. 110-4HM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R