BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 6685302 · Received July 4, 2017

    Report

    Report Number
    9710014-2017-00545
    Event Type
    Injury
    Date Received
    July 4, 2017
    Report Date
    July 10, 2017
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE INVESTIGATION DID NOT SHOW ANY DEVICE DEFECT WHICH IS EXPECTED TO BE PRESENT WHILST IMPLANTED. ACCORDING TO THE RECEIVED INFORMATION, THE USER UNDERWENT A REVISION SURGERY DUE TO MIGRATION OF THE ACTIVE ELECTRODE ARRAY OUT OF COCHLEA. DURING THE REPOSITIONING SURGERY THE SURGEON INADVERTENTLY DAMAGED THE HOUSING OF THE IMPLANT AND THE CONCERNED DEVICE WAS EXPLANTED. DURING INVESTIGATION, SEVERAL CUTS INTO THE SILICONE OVERMOLD AT STIMULATOR HOUSING WERE FOUND. THE INVESTIGATION RESULTS APPEAR TO MATCH THE PROBLEMS MENTIONED IN THE USER REPORT. ADDITIONALLY, RECEIVED IN SITU MEASUREMENTS SHOW A TRANSIENT SHORT CIRCUIT WHICH COULD HAVE LED TO A REDUCED BENEFIT. THE ORIGIN OF THIS SHORT CIRCUIT REMAINS UNKNOWN SINCE IT COULD NOT BE REPRODUCED DURING DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    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 · 1

    ADDITIONAL INFORMATION: AN INITIAL MDR WAS SENT BUT THE SYSTEM SHOWED AN ERROR MESSAGE THAT A DUPLICATE REPORT WAS SEND, HOWEVER NO PREVIOUS REPORT WITH THE SAME MANUFACTURING REPORT NUMBER WAS ISSUED. OUR QMS DEPARTMENT TOGETHER WITH FDA ARE INVESTIGATING ON THIS CIRCUMSTANCE. TO AVOID A LATE REPORT WE SEND THIS FOLLOW UP REPORT.

    Description of Event or Problem · 1

    THE EXPLANTED DEVICE WAS RECEIVED AT HQ (B)(4). DUE TO ELECTRODE ARRAY MIGRATION, INITIALLY A REVISION SURGERY TO RE-INSERT THE ELECTRODE WAS PLANNED. DURING THIS SURGERY, THE SURGEON DAMAGED THE HOUSING OF THE IMPLANT AND PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE.

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED AT HQ (B)(4). ACCORDING TO THE DEVICE EXPLANTATION REPORT FORM THE DEVICE DID MIGRATE AND PATIENT WAS RE-IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FIELD.

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED AT HQ (B)(4). ACCORDING TO THE DEVICE EXPLANTATION REPORT FORM THE DEVICE DID MIGRATE AND PATIENT WAS RE-IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465734 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 56 YR Required Intervention