BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3930039 · Received March 10, 2014

    Report

    Report Number
    9710014-2014-00123
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 27, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    ACCORDING TO THE REPORT OF (B)(6) 2014, INFORMATION WAS RECEIVED THAT THE PATIENT IS TO BE RE-IMPLANTED. NO FURTHER INFORMATION WAS GIVEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143745 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM PULSAR COMPRESSED MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR