BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 8059156 · Received November 12, 2018

    Report

    Report Number
    9710014-2018-00926
    Event Type
    Injury
    Date Received
    November 12, 2018
    Report Date
    February 18, 2019
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    UDI-DI
    09008737094058
    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 BEEN EXPLANTED AND SHOULD 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: DEVICE INVESTIGATIONS DID NOT REVEAL ANY DEVICE DEFECT OR PROBLEM WHICH IS EXPECTED TO HAVE BEEN PRESENT WHILST IMPLANTED. THIS FINDING WAS EXPECTED, BECAUSE ACCORDING TO THE PATIENT REPORT THE ACTIVE ELECTRODE WAS FOUND PARTIALLY OUTSIDE OF COCHLEA, AS CONFIRMED BY POST-OPERATIVE DIAGNOSTIC IMAGING. THE CONCERNED DEVICE HAS BEEN EXPLANTED. THE INVESTIGATION RESULTS APPEAR TO MATCH THE PROBLEMS MENTIONED IN THE PATIENT REPORT. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    AT INITIAL ACTIVATION THE RECIPIENT WAS NOT ABLE TO PERCEIVE SOUNDS ON BASAL CHANNELS 7-12, EVEN WITH MAXIMUM STIMULATION LEVELS. THERE IS NO REPORT OF ACCIDENT OR TRAUMA. THE RECIPIENT HAS BEEN RE-IMPLANTED.

    Description of Event or Problem · 0

    AT INITIAL ACTIVATION THE RECIPIENT WAS NOT ABLE TO PERCEIVE SOUNDS ON BASAL CHANNELS 7-12, EVEN WITH MAXIMUM STIMULATION LEVELS. THERE WAS NO REPORT OF ACCIDENT OR TRAUMA. ACCORDING TO INTERNAL REGISTRATION INFORMATION, A FULL INSERTION WAS ACHIEVED AT IMPLANTATION. RECENT CT SCAN SHOWED 6 EXTRA-COCHLEAR CHANNELS. IN SITU MEASUREMENTS SHOW NORMAL IMPEDANCES ACROSS THE ARRAY. NO COCHLEAR ANOMALIES WERE REPORTED AND CT DID NOT SHOW ANY OBSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900713 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1200 SYNCHRONY PIN 09008737094058

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention