BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 6456098 · Received April 4, 2017

    Report

    Report Number
    9710014-2017-00272
    Event Type
    Malfunction
    Date Received
    April 4, 2017
    Report Date
    April 12, 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

    ADDITIONAL INFORMATION: THE RETURNED DEVICE SUPPLEMENTAL SHEET FOR RECHARGEABLE BATTERIES WAS INSPECTED UPON ARRIVAL. ACCORDING TO THE RECEIVED INFORMATION, LEAKING ELECTROLYTE 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

    ACCORDING TO THE RECEIVED INFORMATION, THE PATIENT'S DACAPO POWER PACK HAD AN ELECTROLYTE LEAKAGE, HOWEVER NEITHER PATIENT CONTACT TO BATTERY CHEMISTRY NOR ANY INJURIES WERE REPORTED. A ROOT CAUSE FOR THE MALFUNCTION COULD NOT BE DETERMINED AS THE DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE SHOULD 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

    THE RECIPIENT HAD NOTICED A LEAKAGE OF ELECTROLYTE WHILST USING THE DEVICE. NEITHER RECIPIENT CONTACT TO THE ELECTROLYTE NOR ANY INJURIES ARE REPORTED. THE AFFECTED DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THE PATIENT HAD NOTICED A LEAKAGE OF ELECTROLYTE WHILST USING THE DEVICE. NEITHER PATIENT CONTACT TO THE ELECTROLYTE NOR ANY INJURIES ARE REPORTED. THE AFFECTED DEVICE WILL NOT BE RETURNED TO HQ (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD NOTICED A LEAKAGE OF ELECTROLYTE WHILST USING THE DEVICE. THERE WAS NO DAMAGE TO THE HEALTH OF THE PATIENT. THE AFFECTED DEVICE WILL NOT BE RETURNED TO HQ (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238271 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM EXTERNAL COMPONENT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH DACAPO POWERPACK 1111S077

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR