BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPI.CABL, CYL.FEMALE, 6 PIN, 8FT, 2PC

    MDR report key: 1854575 · Received September 9, 2010

    Report

    Report Number
    9612007-2010-00024
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    IKD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON AN UNK DATE, AN (B)(6) MALE PT WAS HOOKED UP TO THE GRID AT THE TIME OF THE CONNECTORS FAILING. THE CABLE WAS CONNECTED TO THE PT. THE CABLE WAS ONE THAT HAS AN EXTENSION AND THAT WAS WHERE THE BREAK OCCURRED. THE CABLE BECAME DISASSEMBLED AT THE QUICK CONNECT SITE. WIRES FELL OUT OF QUICK CONNECT SITE. THE CONNECTOR THAT FAILED WAS UNDER THE HEAD WRAP. ALL OF THE BANDAGES HAD TO COME OFF TO TROUBLE SHOOT THE PROBLEM. THE ONLY REASON THAT THE FAILURE WAS NOTICED WAS BECAUSE OF THE LARGE AMOUNT OF ARTIFACT ON THE RECORDING. THE RECORDING WAS COMPROMISED. THE RECORDING WAS SIGNIFICANTLY DELAYED POST SURGERY. THE CABLE WAS REPLACED. THERE WAS NO INJURY TO THE PT. THERE WAS NO SIGNIFICANT CHANGES IN THE PT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPI.CABL, CYL.FEMALE, 6 PIN, 8FT, 2PC NA IKD INTEGRA NEUROSCIENCES IMPLANTS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR