BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 2932255 · Received January 25, 2013

    Report

    Report Number
    3006556115-2013-00039
    Event Type
    Injury
    Date Received
    January 25, 2013
    Report Date
    January 4, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED FACIAL PARALYSIS POST IMPLANT SURGERY. THE PT WAS PRESCRIBED VALTREX (DOSAGE UNK) BUT DID NOT SHOW ENOUGH IMPROVEMENT AND WAS THEREFORE PRESCRIBED PHYSICAL THERAPY. THE PHYSICAL THERAPY HAS RESULTED IN THE MOST IMPROVEMENT. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO; ONCE MORE INFO IS OBTAINED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36259 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention