BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3012309 · Received March 12, 2013

    Report

    Report Number
    3006556115-2013-00080
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS EXPLANTED FOR MEDICAL REASONS. EXTERNAL VISUAL INSPECTION OF THE DEVICE REVEALED THE ELECTRODE WAS SEVERED NEAR THE ARRAY PRIOR TO RECEIPT. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. THE DEVICE PASSED THE PHOTOGRAPHIC IMAGING INSPECTION. SYSTEM LOCK WAS OBTAINED. DUE TO THE ELECTRODE CONDITION, ONE OF THE ELECTRICAL TESTS COULD NOT BE PERFORMED. THE DEVICE PASSED THE ELECTRICAL AND MECHANICAL TESTS PERFORMED. THE PT IS DOING WILL. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT HAD NO AUDITORY RESPONSE. A CT SCAN WAS PERFORMED AND FOUND THE ELECTRODES WERE NOT POSITIONED CORRECTLY. THE PT'S DEVICE WAS EXPLANTED AND THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE ON THE CONTRALATERAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104312 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention