BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AURAGEN STRIP 6 CTS

    MDR report key: 3855706 · Received April 21, 2014

    Report

    Report Number
    9612007-2014-00013
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 15, 2014
    Report Date
    April 1, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    GYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STRIP ELECTRODE DID NOT WORK. THERE WAS NO PT INJURY AND NO DELAY IN SURGERY. ADDITIONAL INFO WAS REQUESTED AND ON (B)(6) 2014, THE FOLLOWING WAS PROVIDED BY THE SALES REP: (B)(6) YEAR OLD MALE PT WITH AN UNDERLYING MED CONDITION OF A BRAIN TUMOR UNDERWENT A CRANIOTOMY. THE ELECTRODE WAS PUT IN TO THE MONITOR, READING DEPRESSION POSTOPERATIVELY; THE ELECTRODE WAS NOT WORKING. IT WAS UNK WHICH OF THE 6 CONTACTS DID NOT WORK. THE STRIP ELECTRODE WAS TAKEN OUT OF THE PT IN THE INTENSIVE CARE UNIT (ICU). THEY DID NOT PUT IN ANOTHER ONE EVEN THOUGH THERE WERE OTHER STRIP ELECTRODES AVAILABLE TO BE USED. THEY DID NOT MONITOR THE PT WHEN THE STRIP ELECTRODE WAS NOT WORKING CORRECTLY. PT OUTCOME WAS UNK. THE LOT NUMBER OF THE PRODUCT WAS ALSO UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242107 AURAGEN STRIP 6 CTS AURAGEN STRIP ELECTRODE GYC INTEGRA NEUROSCIENCES IMPLANTS S.A. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR