BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3082464 · Received April 24, 2013

    Report

    Report Number
    9710014-2013-00162
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO INNSBRUCK WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DECLINE IN HEARING PERFORMANCE WAS NOTICED BY THE PT'S GUARDIANS IN (B)(6) 2013. A RESPONSE OF THE AUDITORY NERVE WAS OBTAINED ONLY ON THE BASAL CHANNELS. THE PT USED ONLY 4 CHANNELS, CHANNELS 8-11. DIAGNOSTIC IMAGING SHOWED THE ELECTRODE ARRAY TO BE INSIDE OF THE COCHLEA. THE PT WAS RE-IMPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175920 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM PULSAR STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention