BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3994417 · Received July 23, 2014

    Report

    Report Number
    9710014-2014-00377
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. ADDITIONALLY, THE ACTIVE ELECTRODE WAS FOUND PARTIALLY OUTSIDE OF COCHLEA, AS CONFIRMED BY DIAGNOSTIC IMAGING, WHICH MAY HAVE CONTRIBUTED TO THE OBSERVED SYMPTOMS. THE INVESTIGATION RESULTS APPEAR TO MATCH THE PROBLEMS MENTIONED TO THE PATIENT REPORT. THIS 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 MFR FOR EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ACCORDING TO THE CURRENTLY AVAILABLE INFORMATION, IT APPEARS THERE IS A PROBLEM WITH THE ACTIVE ELECTRODE, POSSIBLY CAUSED BY EXCESSIVE MECHANICAL STRESS. ADDITIONALLY THE SYMPTOMS MIGHT BE CONTRIBUTED TO BY A PARTIAL MIGRATION OF THE ACTIVE ELECTRODE OUT OF COCHLEA. HOWEVER TO DETERMINE AN EXACT ROOT CAUSE, A DEVICE INVESTIGATION IS NECESSARY. THE COMPLAINT WILL BE RE-OPENED IF FURTHER RELEVANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN SITU TESTING SHOWED 6 ELECTRODE CHANNELS WITH HI STATUS. NO ACCIDENT OR TRAUMA IS KNOWN. DUE TO NO HEARING PERCEPTION 2 ELECTRODE CHANNELS WERE DISABLED. THE PATIENT NOW HAS 4 WORKING ELECTRODE CHANNELS AND PERFORMANCE HAS DECREASED. DIAGNOSTIC IMAGING SHOWS THE ELECTRODE TO BE PARTIALLY INSIDE THE COCHLEA, WITH THE FOUR MOST BASAL CHANNELS OUTSIDE THE COCHLEA. THE PATIENT WAS RE-IMPLANTED ON (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN-SITU TESTING SHOWED 6 ELECTRODE CHANNELS WITH HIGH IMPEDANCE STATUS. NO ACCIDENT OR TRAUMA IS KNOWN. DUE TO NO HEARING PERCEPTION 2 ELECTRODE CHANNELS WERE DISABLED. THE PATIENT NOW HAS 4 WORKING ELECTRODE CHANNELS AND PERFORMANCE HAS DECREASED. THE PATIENT IS TO BE RE-IMPLANTED BUT NO INFORMATION ABOUT A POSSIBLE DATE HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN SITU, TESTING SHOWED 6 ELECTRODE CHANNELS WITH HI STATUS. NO ACCIDENT OR TRAUMA IS KNOWN. DUE TO NO HEARING PERCEPTION 2 ELECTRODE CHANNELS WERE DISABLED. THE PT NOW HAS 4 WORKING ELECTRODE CHANNELS AND PERFORMANCE HAS DECREASED. DIAGNOSTIC IMAGING WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431877 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA +FLEX28 MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention