BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2850573 · Received November 20, 2012

    Report

    Report Number
    9710014-2012-00425
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    June 29, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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

    ACCORDING TO THE REPORT OF (B)(4) 2012, A COIL RETENTION ISSUE WAS ASSESSED DURING AN APPOINTMENT ON (B)(6). AT THE PT'S ACTIVATION APPOINTMENT ON (B)(6), THE COIL WOULD NOT MAGNETICALLY ADHERE TO THE IMPLANT SITE. A 4-DOT MAGNET COIL WOULD NOT KEEP THE COIL ON THE HEAD OVER THE IMPLANT SITE. HAIR REMOVAL AROUND THE IMPLANT SITE AND A TIGHT HEAD BAND WITH A SINGLE 4-DOT MAGNET WERE WORN DURING WAKING HOURS FROM (B)(6). HOWEVER, THE IMPLANT COULD ONLY BE STIMULATED WITH EXTREME PHYSICAL PRESSURE BEING PLACED ON THE COIL ON THE HEAD, OR INTO THE DIB COIL. SKIN FLAP THICKNESS WAS NOT MEASURED DURING IMPLANTATION SURGERY. ON (B)(6), THE PT UNDERWENT REVISION SURGERY, IN WHICH THE SKIN FLAP WAS THINNED OUT. REACTIVATION WAS DUE TO TAKE PLACE ON (B)(6), BUT WAS CANCELED DUE TO A LARGE HEMATOMA OVER THE IMPLANT SITE. THE PT WAS SEEN ON (B)(6), BUT ACTIVATION WAS UNABLE TO TAKE PLACE DUE TO COIL RETENTION ISSUES. THE PT WAS EXPLANTED OF THE DEVICE ON (B)(6).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention