BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2023559 · Received March 16, 2011

    Report

    Report Number
    9710014-2011-00089
    Event Type
    Injury
    Date Received
    March 16, 2011
    Report Date
    March 11, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO (B)(4) WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPARENTLY THE PATIENT WAS RE-IMPLANTED AS THE ELECTRODE SHOWED A PROBLEM. TESTING CARRIED OUT ON (B)(6) 2010 SHOWS ELECTRODE CHANNELS 2, 7, 11 AND 12 IN STATUS HI. AS PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011, THE PATIENT HAD A TRAUMA, AFTER WHICH TESTING PERFORMED ON (B)(6) 2010 SHOWED THAT THE DEVICE HAS MALFUNCTIONED. THE PATIENT WAS RE-IMPLANTED ON (B)(6) 2011.

    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 PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention