BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION IMPLANT

    MDR report key: 3983272 · Received July 3, 2014

    Report

    Report Number
    3006556115-2014-00318
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT'S DEVICE HAS NO STIMULATION RESPONSE FOR SEVERAL ELECTRODES. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. REIMPLANTATION SURGERY WILL BE SCHEDULED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO. ONCE ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392169 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR