BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1940333 · Received December 20, 2010

    Report

    Report Number
    9710014-2010-00393
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 20, 2010
    Report Date
    December 21, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED , IT IS TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DID NOT RESPOND TO NAME CALL FOR THE PAST FEW DAYS. THE AUDITORY PERFORMANCE HAD DECREASED CONSIDERABLY. AN ACCIDENT WAS NOT REPORTED. TESTING CARRIED OUT ON (B)(6), 2010, SHOWS STATUS 'OK' ON ALL CHANNELS WITH CHANNELS 3 AND 5 HAVE IN INCREASED IMPEDANCE. ON BEHAVIORAL MAPPING THE CHILD RESPONDS ONLY TO CHANNEL 1. AN X-RAY TAKEN ON (B)(6), SHOWS THAT 7-8 CHANNELS HAVE MIGRATED OUT OF THE COCHLEA. A REVISION SURGERY WAS CARRIED OUT IN (B)(6) 2010 WHERE THE SAME ELECTRODE ARRAY WAS RE-INSERTED INTO THE COCHLEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH C40+

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention