BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT TUNNELER

    MDR report key: 2701874 · Received August 14, 2012

    Report

    Report Number
    9612007-2012-00026
    Event Type
    Malfunction
    Date Received
    August 14, 2012
    Date of Event
    July 17, 2012
    Report Date
    August 14, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS SA
    Product Code
    GYK
    PMA / PMN Number
    K932273
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A SHUNT TUNNELER WAS BEING USED DURING A VENTRICULAR PERITONEAL (VP) SHUNT AND THE SURGEON DESCRIBED THE TUNNELER AS BEING "WEAK AND BENDS," AND IS NOT SUITABLE FOR TUNNELING. THE AGE AND THE GENDER OF THE PT IS UNK. THE PT WAS ANESTHETIZED AND THE PROCEDURE WAS DELAYED FOR 15 MINUTES AS A RESULT OF THIS ISSUE. THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHUNT TUNNELER VALVE ACCESSORIES GYK INTEGRA NEUROSCIENCES IMPLANTS SA 170524

    Patients

    Seq Age Sex Outcome Treatment
    1