BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 7705746 · Received July 20, 2018

    Report

    Report Number
    9710014-2018-00561
    Event Type
    Injury
    Date Received
    July 20, 2018
    Date of Event
    June 26, 2018
    Report Date
    November 22, 2018
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    UDI-DI
    09008737094041
    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

    (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.

    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). CONCLUSION: BASED ON THE RECEIVED INFORMATION, THE DEVICE WAS NOT PROVIDING SATISFACTORY BENEFIT TO THE RECIPIENT DUE TO A POST-OPERATIVE MIGRATION OF THE ACTIVE ELECTRODE ARRAY OUT OF THE COCHLEA, AS CONFIRMED BY POST-OPERATIVE DIAGNOSTIC IMAGING. A FULL INSERTION WAS ACHIEVED AT THE INITIAL IMPLANTATION. A REVISION SURGERY TO RE-INSERT THE ELECTRODE WAS SUCCESSFULLY PERFORMED; THUS, THE CONCERNED DEVICE REMAINS IMPLANTED AND IN USE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    CT SCAN CONFIRMED THE ELECTRODE ARRAY IS NOT FULLY INSERTED. RE-INSERTION OR RE-IMPLANTATION IS PLANNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THERE IS NO REPORT OF AN ACCIDENT OR TRAUMA. PER INTERNAL REGISTRATION INFORMATION, A FULL INSERTION WAS ACHIEVED AT IMPLANTATION. CT SCAN CONFIRMED THE ELECTRODE ARRAY WAS NOT FULLY INSERTED. RE-INSERTION SURGERY TOOK PLACE ON (B)(4) 2018. THE ARRAY HAD MIGRATED FROM THE COCHLEA. THE ARRAY WAS RE-INSERTED TO THE MARKER RING WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549228 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1200 SYNCHRONY 09008737094041

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention