BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 4840415 · Received June 11, 2015

    Report

    Report Number
    9710014-2015-00405
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    March 11, 2015
    Report Date
    May 12, 2016
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MFR FOR EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Additional Manufacturer Narrative · 1

    CONCLUSION: BASED ON THE DEVICE INVESTIGATION RESULTS AND INFORMATION FROM THE FIELD, THE EXPERIENCED PROBLEMS MIGHT BE DEVICE UNRELATED AND POSSIBLY ATTRIBUTABLE TO THE REPORTED TRAUMA OR TO SOME COCHLEA CONDITIONS. THE DEVICE IS WORKING WITHIN NORMAL LIMITS DURING INVESTIGATION. DURING RE-IMPLANTATION SURGERY THE SURGEON COULD ONLY ACHIEVE A PARTIAL INSERTION OF THE ELECTRODE ARRAY ON THE CONCERNED SIDE. THE PATIENT WAS RE-IMPLANTED ON THE CONTRALATERAL SIDE WITH NO COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN SITU TESTING SHOWED 4 ELECTRODE CHANNELS WITH STATUS HI. AN ACCIDENT OR TRAUMA IS KNOWN. DIAGNOSTIC IMAGING SHOWED NORMAL ELECTRODE POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN-SITU TESTING SHOWED 4 ELECTRODE CHANNELS WITH STATUS HI. AN ACCIDENT OR TRAUMA IS KNOWN. DIAGNOSTIC IMAGING SHOWED NORMAL ELECTRODE POSITION. THE PATIENT HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383356 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1000 MED-EL CONCERT

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention