BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2900873 · Received January 2, 2013

    Report

    Report Number
    9710014-2012-00493
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 28, 2012
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD 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 DURING THE IMPLANTATION SURGERY SEVERAL CHECKS WERE PERFORMED TO ASSESS THE STATUS OF THE COCHLEAR IMPLANT. SHORT-CIRCUITS APPEARED IN ALL THE ELECTRODES AND THE GROUND PATH IMPEDANCE COULD NOT BE DETERMINED. THE PERSON WHO WAS CARRYING OUT THE MEASUREMENTS IN THE SURGICAL ROOM THOUGHT THAT THE IMPLANT WAS DAMAGED, SO IT WAS REMOVED AND ANOTHER IMPLANT WAS USED. NEW CHECKS WERE PERFORMED BUT THE SAME RESULTS WERE OBTAINED WITH THE SECOND IMPLANT AND SOME PERIOSTEUM THAT WAS STILL OVER THE BONE WAS REMOVED. THEN CHECKS WERE CARRIED OUT AND IT WAS SEEN THAT THE IMPLANTED DEVICE WAS FUNCTIONAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention