BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 5111046 · Received September 29, 2015

    Report

    Report Number
    9710014-2015-00720
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    September 11, 2015
    Report Date
    May 12, 2016
    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

    (B)(4). 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 · 1

    (B)(4). CONCLUSION: DEVICE INVESTIGATION DID NOT REVEAL ANY DEVICE DEFECT WHICH IS EXPECTED TO HAVE BEEN PRESENT WHILST IMPLANTED. BASED ON THE INFORMATION RECEIVED, 8 ELECTRODES WERE OUT OF COCHLEA, WITH THE REMAINING 4 CHANNELS INSERTED IN THE SCALA VESTIBULI. A FULL INSERTION WAS REPORTEDLY ACHIEVED AT INITIAL IMPLANTATION. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REFERRED NO RESPONSE WITH THE COCHLEAR IMPLANT. THE PATIENT WAS RE-IMPLANTED ON (B)(6) 2015. REPORTEDLY, DURING THE RE-IMPLANTATION SURGERY, COCHLEAR OSSIFICATION AS WELL AS 8 EXTRA-COCHLEAR CHANNELS WERE OBSERVED, THE 4 REMAINING CHANNELS HAD BEEN INSERTED IN THE SCALA VESTIBULI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO RESPONSE WITH THE COCHLEAR IMPLANT. REPORTEDLY, DURING THE RE-IMPLANTATION SURGERY, COCHLEAR OSSIFICATION AS WELL AS 8 EXTRA-COCHLEAR CHANNELS WERE OBSERVED, THE 4 REMAINING CHANNELS HAD BEEN INSERTED IN THE SCALA VESTIBULI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641224 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1000 MED-EL CONCERT PIN

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention