BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3770076 · Received January 28, 2014

    Report

    Report Number
    3006556115-2014-00007
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 7, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY HAS NO LOCK BETWEEN THE INTERNAL COCHLEAR IMPLANT AND THE EXTERNAL EQUIPMENT. EXTERNAL EQUIPMENT WAS EXCHANGED, HOWEVER THIS DID NOT RESOLVE THE ISSUE. REVISION SURGERY HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61079 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR