BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 7348078 · Received March 19, 2018

    Report

    Report Number
    9710014-2018-00190
    Event Type
    Injury
    Date Received
    March 19, 2018
    Date of Event
    March 12, 2018
    Report Date
    November 19, 2018
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH AND VIBRANT MED-EL SUBMIT MDR REPORTS ON BEHALF OF MED-EL CORPORATION (EXEMPTION NUMBER E2015033). CONCLUSIONS: BASED ON THE INFORMATION RECEIVED FROM THE FIELD, THE ACTIVE ELECTRODE WAS FOUND TO HAVE MIGRATED PARTIALLY OUT OF THE COCHLEA. A FULL INSERTION WAS REPORTED AT THE TIME OF IMPLANTATION. A REVISION SURGERY TO RE-INSERT THE ACTIVE ELECTRODE INTO THE COCHLEA WAS CARRIED OUT AND IT WAS SEEN THAT TIGHT SCAR TISSUE HAD FORMED THROUGHOUT THE MASTOID CAVITY. THIS DENSE SCAR TISSUE FORMATION WAS LIKELY THE CAUSE FOR THE OBSERVED DISPLACEMENT, AS THE SCAR TISSUE SEEMED TO HAVE GRABBED AND PULLED THE ELECTRODE ARRAY. ADDITIONALLY, THE RECIPIENT SUFFERS OF OTOSCLEROSIS AND CHANGES OF FENESTRAL OTOSCLEROSIS HAVE BEEN OBSERVED WITH IMAGING POST-IMPLANTATION. THE RE-INSERTION WAS REPORTEDLY DONE WITHOUT PROBLEMS. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    (B)(4). (EXEMPTION NUMBER E2015033). 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 · 0

    IT WAS INITIALLY REPORTED THAT THE RECIPIENT HAD NOT MET THE EXPECTED LEVEL OF PROGRESS WITH THE COCHLEAR IMPLANT. THE USER WAS SEEN FOR PROGRAMMING ON (B)(4) 2018 AND REFERRED FOR A CT SCAN. THE ELECTRODE ARRAY WAS SUCCESSFULLY RE-INSERTED ON (B)(4) 2018. IT WAS NOTED THAT THE SKIN BEHIND THE EAR PRIOR TO SURGERY WAS CONCAVE; A NOTE OF THIS NEGATIVE PRESSURE WAS MADE. AFTER THE MASTOID WAS OPENED IT WAS EVIDENT THAT VERY DENSE, TIGHT SCAR TISSUE WAS FORMED THROUGHOUT THE MASTOID CAVITY. IT APPEARED THIS SCAR TISSUE HAD COME INTO CONTACT WITH THE ARRAY AND MAY HAVE PULLED IT OUT OF THE COCHLEA.

    Description of Event or Problem · 0

    THE RECIPIENT HAS NOT MET THE EXPECTED LEVEL OF PROGRESS WITH HIS COCHLEAR IMPLANT. REVISION WITH A SHORTER ELECTRODE ARRAY IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193094 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1200 SYNCHRONY

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention