BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3213946 · Received July 3, 2013

    Report

    Report Number
    9710014-2013-00272
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 1, 2013
    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 BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MFR 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 A CT SCAN, PERFORMED A FEW DAYS AFTER IMPLANTATION, SHOWED THAT THE ELECTRODE ARRAY WAS LOCATED IN THE CAROTID CANAL. THE PATIENT WAS EXPLANTED OF THE DEVICE. IMPLANTATION ON THE CONTRALATERAL SIDE MAY BE CONSIDERED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304864 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM PULSAR MEDIUM MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention