BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 8300868 · Received February 4, 2019

    Report

    Report Number
    9710014-2019-00094
    Event Type
    Injury
    Date Received
    February 4, 2019
    Date of Event
    January 23, 2019
    Report Date
    September 23, 2019
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    UDI-DI
    09008737093969
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ACCORDING TO THE RECEIVED INFORMATION, TEMPORARY SYMPTOMS OBSERVED DURING THE FIRST ACTIVATION ATTEMPT WERE MOST LIKELY RELATED TO COMPLICATIONS DERIVED FROM THE SURGICAL TECHNIQUE REQUIRED DURING IMPLANTATION. ADDITIONALLY, A COMPLETE INSERTION COULD NOT BE ACHIEVED AT IMPLANTATION WITH POSTOPERATIVE DIAGNOSTIC IMAGING INDICATING AN ADDITIONAL PARTIAL ELECTRODE MIGRATION OUTSIDE OF THE COCHLEA. HOWEVER, THE USER COULD BE SUCCESSFULLY ACTIVATED WITH THE REMAINING ELECTRODES. THE DEVICE REMAINS IMPLANTED AND IN USE. NO FURTHER INTERVENTION IS CONSIDERED.

    Description of Event or Problem · 0

    THE RECIPIENT WAS BILATERALLY IMPLANTED. DURING ACTIVATION, IT WAS OBSERVED THAT THE CONCERNED LEFT DEVICE ELECTRODE LEAD WAS EXPOSED, AND BLOOD COULD BE SEEN IN THE LEFT EXTERNAL AUDITORY CANAL. ONLY THE CONTRALATERAL DEVICE WAS ACTIVATED, BEING THE CONCERNED LEFT DEVICE ACTIVATION POSTPONED. AS PER LATEST INFORMATION RECEIVED, THE USER WAS ACTIVATED WITHOUT ANY PROBLEMS. EVERYTHING WORKED CORRECTLY DURING THE FITTING SESSION. NO FURTHER INTERVENTION IS PLANNED.

    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.

    Description of Event or Problem · 1

    THE RECIPIENT WAS BILATERALLY IMPLANTED. ON ACTIVATION, IT WAS OBSERVED THAT THE LEFT ELECTRODE LEAD WAS EXPOSED AND BLOOD COULD BE SEEN IN THE LEFT EXTERNAL AUDITORY CANAL. CT IMAGING IS AWAITED TO CONFIRM THE ELECTRODE POSITION ON THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95918 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1200 SYNCHRONY PIN 09008737093969

    Patients

    Seq Age Sex Outcome Treatment
    1 17 MO Required Intervention