BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT TUNNELER

    MDR report key: 3663245 · Received December 20, 2013

    Report

    Report Number
    9612007-2013-00028
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Report Date
    December 5, 2013
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    GYK
    PMA / PMN Number
    K932273
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. THE DEVICE WAS DISCARDED BY THE CUSTOMER. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUNNELER WAS TOO SOFT AND TOO COMPLICATED TO GUIDE. THE PRODUCT WAS IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT INJURY OR DEATH ALLEGED. THIS EVENT LED TO AN INCREASE IN SURGERY TIME (EXACT TIME NOT PROVIDED). THE PRODUCT WAS THROWN OUT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670505 SHUNT TUNNELER VALVE ACCESSORIES GYK INTEGRA NEUROSCIENCES IMPLANTS S.A. 172985

    Patients

    Seq Age Sex Outcome Treatment
    1