BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K¿ IMPLANT

    MDR report key: 5779288 · Received July 8, 2016

    Report

    Report Number
    3006556115-2016-00299
    Event Type
    Injury
    Date Received
    July 8, 2016
    Report Date
    June 17, 2016
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RECIPIENT WAS REPORTEDLY PRESCRIBED INTRAVENOUS VANCOMYCIN AND CEFTRIAXONE 2G FOR THREE DAYS. THE RECIPIENT WAS SWITCHED TO INTRAVENOUS CEFTRIAXONE, 2G A DAY FOR FOURTEEN DAYS POSTOPERATIVELY. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT'S MEDICAL ISSUE HAS RESOLVED.

    Additional Manufacturer Narrative · 1

    UDI NUMBER: NA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXTERNAL VISUAL INSPECTION REVEALED THE ELECTRODE WAS CUT PRIOR TO RECEIPT. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. THE PHOTOGRAPHIC IMAGING INSPECTION CONFIRMED CUT ELECTRODE WIRES. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. SYSTEM LOCK WAS VERIFIED. THE DEVICE PASSED ALL OF THE ELECTRICAL TESTS PERFORMED. THE DEVICE FAILED THE RESIDUAL GAS ANALYSIS TEST. THIS DEVICE WAS EXPLANTED FOR MEDICAL REASONS. THE DEVICE PASSED THE ELECTRICAL TESTS PERFORMED. HOWEVER, THIS DEVICE HAD MOISTURE THAT EXCEEDED THE RESIDUAL GAS ANALYSIS TEST LIMIT. LEAK TESTING DID NOT REVEAL ANY LEAKS. A CAPA WAS IMPLEMENTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE RECIPIENT REPORTEDLY EXPERIENCED AN INFECTION. THE RECIPIENT WAS PRESCRIBED IV ANTIBIOTICS FOR FOUR DAYS, HOWEVER, THE TREATMENT WAS NOT SUCCESSFUL. THE RECIPIENT'S MAGNET WAS DISLODGED. THE RECIPIENT'S DEVICE WILL BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433495 HIRES 90K¿ IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention