BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN

    MDR report key: 2052270 · Received April 4, 2011

    Report

    Report Number
    2052270
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 4, 2011
    Manufacturer
    CODMAN & SURTLEFF, INC
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTRACRANIAL PRESSURE DEVICE (ICP) IMPLANTED. AFTER INSERTION THE DEVICE INDICATED NEGATIVE PRESSURE READINGS. SURGEON DECIDED TO LEAVE ICP IN PLACE. DURING COURSE DEVICE INDICATED BOTH POSITIVE AND NEGATIVE PRESSURES. DEVICE REMOVED 3 DAYS LATER AND DISTAL TIP OF CATHETER BROKE OFF WITHIN PATIENT AND REQUIRED SUBSEQUENT REMOVAL AT BEDSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN CODMAN MICROPROCESSOR ICP TRANSDUCER GWM CODMAN & SURTLEFF, INC * 500284

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR