BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 6916746 · Received October 5, 2017

    Report

    Report Number
    9710014-2017-00825
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    October 2, 2017
    Report Date
    April 25, 2018
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    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 PROBLEMS GIVEN IN THE RECIPIENT REPORT APPEAR TO MATCH THE DAMAGE FOUND. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ACCORDING TO THE CURRENTLY AVAILABLE INFORMATION, DAMAGE TO THE ACTIVE ELECTRODE AS MIGHT BE CAUSED BY AN EXTERNAL MECHANICAL IMPACT APPEARS LIKELY. HOWEVER TO DETERMINE AN EXACT ROOT CAUSE A DEVICE INVESTIGATION OF THE EXPLANTED DEVICE IS NECESSARY. NO PLANS FOR EXPLANTATION HAVE BEEN MADE SO FAR.

    Description of Event or Problem · 1

    THE RECIPIENT HAS LIMITED SOUND PERCEPTION WITH THE DEVICE. REPORTEDLY THE ACCESS TO SOUND HAD DETERIORATED OVER TIME. NO INCIDENT OF ACCIDENT OR TRAUMA AND NO CHANGES IN HEALTH HAVE BEEN RECEIVED FROM THE FAMILY. THE RECIPIENT WAS RE-IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT HAS LIMITED SOUND PERCEPTION WITH THE DEVICE. EXTERNAL PARTS HAVE BEEN CHECKED WITHOUT IMPROVEMENT. FAMILY REPORTS NO INCIDENT OF ACCIDENT OR TRAUMA AND NO CHANGES IN HEALTH. FURTHER CHECKS WILL BE DONE. AS PER NEW INFORMATION RECEIVED A CT SCAN SHOWS THE DEVICE IN THE CORRECT POSITION, NO EXTRUSION IS DETECTED.

    Description of Event or Problem · 1

    THE PATIENT HAS LIMITATED SOUND PERCEPTION WITH THE DEVICE. EXTERNAL PARTS HAVE BEEN CHECKED WITHOUT IMPROVEMENT. FAMILY REPORTS NO INCIDENT OF ACCIDENT OR TRAUMA AND NO CHANGES IN HEALTH. FURTHER CHECKS WILL BE DONE.

    Description of Event or Problem · 1

    THE PATIENT HAS LIMITED SOUND PERCEPTION WITH THE DEVICE. EXTERNAL PARTS HAVE BEEN CHECKED WITHOUT IMPROVEMENT. NO INCIDENT OF ACCIDENT OR TRAUMA AND NO CHANGES IN HEALTH HAVE BEEN RECEIVED FROM THE FAMILY. AS PER FURTHER INFORMATION RECEIVED A CT SCAN SHOWS THE DEVICE IS IN THE CORRECT POSITION, NO EXTRUSION IS DETECTED. THE NEXT STEPS ARE STILL UNDER CONSIDERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697684 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1000 MED-EL CONCERT PIN

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention