BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 6016303 · Received October 11, 2016

    Report

    Report Number
    9710014-2016-00674
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    October 7, 2016
    Report Date
    November 21, 2017
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    (EXEMPTION NUMBER E2015033). (B)(4). ADDITIONAL INFORMATION: ACCORDING TO THE CURRENTLY AVAILABLE INFORMATION, IT APPEARS THAT THERE IS A PROBLEM WITH THE ACTIVE ELECTRODE, POSSIBLY CAUSED BY BROKEN WIRES DUE TO AN EXTERNAL MECHANICAL IMPACT. HOWEVER, TO DETERMINE AN EXACT ROOT CAUSE A DEVICE INVESTIGATION OF THE EXPLANTED DEVICE IS NECESSARY. A DATE FOR RE-IMPLANTATION HAS NOT BEEN MADE AVAILABLE SO FAR. THIS IS A FINAL 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: DAMAGE TO THE ACTIVE ELECTRODE, AS MIGHT BE CAUSED BY AN EXTERNAL MECHANICAL IMPACT, WAS DETERMINED TO BE THE ROOT CAUSE OF DEVICE FAILURE, EVEN THOUGH NO SUCH CAUSAL EVENT LIKE AN ACCIDENT IS MENTIONED IN THE PATIENT REPORT. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    THE PATIENT HAS NO SOUND PERCEPT WITH THE DEVICE. EXTERNAL PARTS HAVE BEEN CHANGED WITHOUT IMPROVEMENT. FAMILY REPORTS NO INCIDENT OF ACCIDENT OR TRAUMA.

    Description of Event or Problem · 0

    THE PATIENT NO LONGER HAS ANY SOUND PERCEPT WITH THE DEVICE. EXTERNAL PARTS HAVE BEEN CHANGED WITHOUT IMPROVEMENT. RE-IMPLANTATION WAS SUGGESTED BY CLINICAL SUPPORT BUT NO FURTHER CONTACT HAS BEEN ESTABLISHED WITH THE PATIENT.

    Description of Event or Problem · 0

    THE RECIPIENT NO LONGER HAS ANY SOUND PERCEPT WITH THE DEVICE. EXTERNAL PARTS HAVE BEEN CHANGED WITHOUT IMPROVEMENT. NO ACCIDENT OR TRAUMA HAS BEEN REPORTED. THE RECIPIENT WAS RE-IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668273 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1000 MED-EL CONCERT

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention