BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 6679972 · Received June 30, 2017

    Report

    Report Number
    9710014-2017-00536
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    February 22, 2017
    Report Date
    September 4, 2017
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD 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

    SINCE THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER FOR EXAMINATION, NO DEVICE INVESTIGATION WAS CONDUCTED. BASED ON THE CURRENTLY AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO ASSIGN A ROOT CAUSE FOR THE REPORTED PROBLEM. DESPITE SEVERAL REQUESTS, NO FURTHER INFORMATION WAS RECEIVED FROM THE FIELD.

    Description of Event or Problem · 1

    PATIENT COMPLAINED HE NEVER DEVELOPED SPEECH UNDERSTANDING WITH THE DEVICE. ALREADY AT ACTIVATION OF THE DEVICE FOUR CHANNELS WERE DISABLED. PATIENT ASKED THE SURGEON TO EVALUATE HIS CONDITION AND TO CONSIDER AN EXPLANTATION AND RE-IMPLANTATION SURGERY. RE-IMPLANTATION WAS DONE ON (B)(6) 2017. THE DEVICE WILL NOT BE RETURNED TO HQ (B)(4) FOR THE NEXT FIVE YEARS.

    Description of Event or Problem · 1

    PATIENT COMPLAINED HE NEVER DEVELOPED SPEECH UNDERSTANDIG WITH THE DEVICE. PATIENT ASKED THE SURGEON TO EVALUATE HIS CONDITION AND TO CONSIDER AN EXPLANTATION AND RE-IMPLANTATION SURGERY. RE-IMPLANATION WAS DONE ON (B)(6)2017. THE DEVICE WILL NOT BE RETURNED TO HQ INNSBRUCK FOR THE NEXT FIVE YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461457 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 66 YR Required Intervention