BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 7002540 · Received November 6, 2017

    Report

    Report Number
    9710014-2017-00933
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Report Date
    April 19, 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

    CONCLUSION: THE RETURNED DEVICE SUPPLEMENTAL SHEET FOR RECHARGEABLE BATTERIES WAS INSPECTED UPON RECEIPT. ACCORDING TO THE RECEIVED INFORMATION, THE HOUSING AND HOUSING LID WAS MECHANICALLY DAMAGED, MOST LIKELY DUE TO EXTERNAL MECHANICAL STRESS. NO LEAKING OF ELECTROLYTE WAS REPORTED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    CONCLUSION: ACCORDING TO THE RECEIVED INFORMATION THE CONCERNED DACAPO POWER PACK HAD A BROKEN HOUSING WITHOUT ELECTROLYTE LEAKAGE; NEITHER PATIENT CONTACT TO BATTERY CHEMISTRY NOR ANY INJURIES WERE REPORTED. NO CAUSE FOR THE MALFUNCTION COULD BE DETERMINED AS THE DEVICE HAS NOT BEEN RECEIVED FOR FAILURE INVESTIGATION. THIS IS A COMBINED INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    THE USER REQUESTED A CHECK OF THE DACAPO POWERPACK DUE TO A BROKEN HOUSING. HOWEVER, NEITHER USER CONTACT TO BATTERY CHEMISTRY NOR ANY INJURIES HAVE BEEN REPORTED. NO ELECTROLYTE LEAKAGE WAS FOUND. THE POWERPACK WILL NOT BE RETURNED TO THE MANUFACTURER DUE TO IATA REGULATION; HOWEVER A SUPPLEMENTAL SHEET FOR THE DACAPO POWERPACK HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    THE USER REQUESTED A CHECK UP OF DACAPO POWERPACK DUE TO BROKEN HOUSING. HOWEVER, NEITHER PATIENT CONTACT TO BATTERY CHEMISTRY NOR ANY INJURIES HAVE BEEN REPORTED. NO ELECTROLYTE LEAKAGE WAS FOUND. THE POWERPACK WILL NOT BE RETURNED TO HQ (B)(4) DUE TO (B)(4) REGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783802 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM EXTERNAL COMPONENT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH DACAPO POWERPACK 1405Y162

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR