BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3830641 · Received May 5, 2014

    Report

    Report Number
    3006556115-2014-00195
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    February 25, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY EXPERIENCING DECREASE IN PERFORMANCE AND THE PT BECAME A NONUSER OF THE DEVICE. TESTING SHOWED THAT THE PATIENT'S DEVICE WAS FUNCTIONING. PROGRAMMING ADJUSTMENTS WERE MADE AND EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THE PT SHOWED NO IMPROVEMENT. THE PT WAS EXPLANTED AND REIMPLANTED WITH ANOTHER COCHLEAR IMPLANT. 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
    267334 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention