BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 4101976 · Received September 15, 2014

    Report

    Report Number
    9710014-2014-00478
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER 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

    RETURNED DACAPO POWER PACK SHOWED A BROKEN HOUSING WITH ELECTROLYTE LEAKAGE. HOWEVER, NEITHER PATIENT CONTACT TO BATTERY CHEMISTRY NOR ANY INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569091 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM DACAPO POWERPACK (TEMPO ACCU WYON) MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH 1202D071

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK