BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 4810490 · Received June 1, 2015

    Report

    Report Number
    9710014-2015-00376
    Event Type
    Injury
    Date Received
    June 1, 2015
    Report Date
    April 13, 2016
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO (B)(4) WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 1

    CONCLUSION: DEVICE INVESTIGATION DID NOT REVEAL ANY DEVICE DEFECT OR MALFUNCTION. THE DEVICE WAS EXPLANTED BECAUSE ART MEASUREMENT COULD NOT BE RECORDED. THE DEVICE IS PERFORMING WITHIN SPECIFICATION DURING INVESTIGATION. NO TECHNICAL FAILURE COULD BE OBSERVED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAS BEEN EXPLANTED BECAUSE AUDITORY NERVE RESPONSE TELEMETRY COULD NOT BE OBTAINED. THE PT HAS BEEN REIMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAS BEEN EXPLANTED BECAUSE AUDITORY NERVE RESPONSE TELEMETRY COULD NOT BE OBTAINED. THE PATIENT HAS BEEN RE-IMPLANTED AND IS PERFORMING WELL WITH THE NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352908 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention