BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 4840416 · Received June 11, 2015

    Report

    Report Number
    9710014-2015-00420
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    UDI-DI
    09008737310882
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION- DAMAGE TO THE ACTIVE ELECTRODE LIKELY CAUSED BY MINUTE DEVICE MOBILITY WAS DETERMINED TO HAVE LED TO DEVICE FAILURE OVER TIME. THE INVESTIGATION RESULTS APPEAR TO MATCH THE SYMPTOMS / PROBLEMS MENTIONED IN THE PATIENT REPORT. THIS IS A FINAL REPORT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DESCRIBED INTERRUPTED ACCESS TO SOUND WITH THE DEVICE WHEN CHEWING. THESE INTERRUPTIONS ARE ACCOMPANIED BY A 'GUITAR' SOUND WHICH STOPS AS SOON ACCESS TO SOUND RETURNS. REIMPLANTATION IS CONSIDERED BUT NOT SCHEDULED YET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DESCRIBED INTERRUPTED ACCESS TO SOUND WITH THE DEVICE WHEN CHEWING. THESE INTERRUPTIONS ARE ACCOMPANIED BY A 'GUITAR' SOUND WHICH STOPS AS SOON ACCESS TO SOUND RETURNS. THE PATIENT HAS BEEN RE-IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381956 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM MI1200 SYNCHRONY PIN MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH 09008737310882

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention