BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 6864106 · Received September 14, 2017

    Report

    Report Number
    9710014-2017-00724
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Report Date
    April 23, 2018
    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

    BASED ON THE RECEIVED INFORMATION, THE DACAPO POWERPACK 1106G047 WAS OBSERVED TO HAVE BEEN LEAKING. THIS MIGHT BE CAUSED BY THE BULGING OF THE HOUSING WHICH OCCURS WHEN THE DEVICE IS NOT REFRESHED/USED FOR A LONG PERIOD OF TIME. THE CONCERNED DEVICE WILL NOT BE SENT BACK FOR INVESTIGATION. THIS IS A COMBINED INITIAL AND FINAL REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE RETURNED DEVICE SUPPLEMENTAL SHEET FOR RECHARGEABLE BATTERIES WAS INSPECTED UPON ARRIVAL. ACCORDING TO THE RECEIVED INFORMATION, A LEAKING AND THEREFORE, MECHANICALLY DAMAGED HOUSING WAS OBSERVED. THE DAMAGE TO THE BATTERY HOUSING WAS CLEARLY THE REASON FOR THE MALFUNCTION OF THE DEVICE. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: BASED ON THE RECEIVED INFORMATION, THE DACAPO POWERPACK (B)(6) WAS OBSERVED TO HAVE BEEN LEAKING. THIS MIGHT BE CAUSED BY THE BULGING OF THE HOUSING WHICH OCCURS WHEN THE DEVICE IS NOT REFRESHED/USED FOR A LONG PERIOD OF TIME. THE CONCERNED DEVICE WILL NOT BE SENT BACK FOR INVESTIGATION. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    PATIENT REQUESTED A CHECK UP FOR DACAPO POWERPACK. ELECTROLYTE LEAKAGE OF DACAPO POWER PACK WAS FOUND AT (B)(4) MED-EL SERVICE _ REPAIR. NEITHER PATIENT CONTACT TO BATTERY CHEMISTRY NOR ANY INJURIES HAVE BEEN REPORTED. THE AFFECTED DEVICE WILL NOT BE RETURNED TO HQ (B)(4) DUE TO IATA REGULATION.

    Description of Event or Problem · 1

    THE USER REQUESTED A CHECK-UP OF THE DACAPO POWERPACK. NEITHER USER CONTACT TO BATTERY CHEMISTRY NOR ANY INJURIES HAVE BEEN REPORTED. THE AFFECTED DEVICE WILL NOT BE RETURNED TO HQ (B)(4) DUE TO IATA REGULATION; BUT A DEVICE SUPPLEMENTAL SHEET WAS RECEIVED AT HQ (B)(4).

    Description of Event or Problem · 1

    PATIENT REQUESTED A CHECK-UP FOR DACAPO POWERPACK. THE AFFECTED DEVICE WILL NOT BE RETURNED TO HQ INNSBRUCK DUE TO IATA REGULATION. NEITHER PATIENT CONTACT TO BATTERY CHEMISTRY NOR ANY INJURIES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644562 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM EXTERNAL COMPONENT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH DACAPO POWERPACK 1106G047

    Patients

    Seq Age Sex Outcome Treatment
    1