BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3931584 · Received June 23, 2014

    Report

    Report Number
    3006556115-2014-00299
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    December 11, 2013
    Report Date
    June 2, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXTERNAL VISUAL INSPECTION REVEALED THE ELECTRODE WAS SLICED AT THE FANTAIL REGION AND AN ELECTRODE WAS EXTRUDED PRIOR TO RECEIPT. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. THE PHOTOGRAPHIC IMAGING INSPECTION CONFIRMED CUT AND BROKEN ELECTRODE WIRES HEAR THE FANTAIL REGION, AND A DAMAGED ARRAY. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. SYSTEM LOCK WAS VERIFIED. THE ELECTRODE CONDITION CAUSED OUT OF RANGE IMPEDANCE VALUES ON SOME ELECTRODES. THE DEVICE PASSED THE ELECTRICAL AND MECHANICAL TESTS PERFORMED. THIS DEVICE WAS EXPLANTED FOR MEDICAL REASONS. THE DEVICE PASSED THE TESTS PERFORMED.

    Description of Event or Problem · 1

    THE PT REPORTEDLY DEVELOPED A STAPH INFECTION AT THE IMPLANT SITE. THE PT WAS TREATED WITH KEFLEX, AUGMENTIN, LIPRO, NEOSPORIN, AND MEDROL FOR 5 MONTHS. ON (B)(6) 2013, THE PT UNDERWENT SURGERY TO REMOVE A BRACKET USED TO SECURE THE DEVICE. THE INFECTION RECURRED. THE PT'S DEVICE WAS EXPLANTED. THE PT IS CURRENTLY HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364579 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention