BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1930675 · Received December 13, 2010

    Report

    Report Number
    9710014-2010-00394
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 25, 2010
    Report Date
    December 7, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DETECTED AT A ROUTINE CHECK IN THE CLINIC, THAT THE PT REACTS BADLY. TESTING REVEALED 2 CHANNELS WITH STATUS HI AND 9 CHANNELS WITH STATUS SC? THE IMPLANT COULD BE FELT VERY WELL AND THE SKIN OVER THE IMPLANT WAS EXTREMELY THIN. A FALL CANNOT BE RULED OUT. THE PT WAS REIMPLANTED ON (B)(6), 2010.

    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 SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention