BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 6812984 · Received August 23, 2017

    Report

    Report Number
    9710014-2017-00690
    Event Type
    Injury
    Date Received
    August 23, 2017
    Date of Event
    August 8, 2017
    Report Date
    March 1, 2018
    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

    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH AND VIBRANT MED-EL SUBMIT MDR REPORTS ON BEHALF OF MED-EL CORPORATION (EXEMPTION NUMBER E2015033). CONCLUSION: BASED ON THE RECEIVED INFORMATION, IT SEEMS THAT THE REPORTED LACK OF HEARING WAS CAUSED BY A POST-OPERATIVE MIGRATION OF THE ACTIVE ELECTRODE ARRAY OUT OF COCHLEA, AS CONFIRMED BY DIAGNOSTIC IMAGES. A FULL INSERTION WAS ACHIEVED AT INITIAL IMPLANTATION. ACCORDING TO THE RECEIVED INFORMATION THE PATIENT SUFFERED FROM INFECTION WHICH PROBABLY FACILITATED THE MIGRATION. A SURGERY TO RE-INSERT THE ELECTRODE WAS SUCCESSFULLY PERFORMED. THE CONCERNED DEVICE REMAINS IMPLANTED AND IN USE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE USER HAS A KNOWN HISTORY OF MIGRATION SINCE (B)(6) 2017. MIGRATION WAS FOLLOWING AN EVENT (COLD AND HOSPITALIZATION AND PLACEMENT OF A PIC LINE) AND THEREFORE 5 CHANNELS WERE DISABLED BECAUSE THEY WERE OUT OF COCHLEA. SINCE (B)(6) 2017 PATIENT IS NOT USING THE DEVICE ANYMORE. AT THE PROGRAMMING VISIT THE AUDIOLOGIST RECOGNIZED HIS MOST COMFORTABLE STIMULATION LEVELS HAVE DECREASED ALTHOUGH THE IN SITU MEASUREMENTS WERE WITHIN NORMAL RANGE. WHEN RECIPIENT IS USING THE PROCESSOR HE HAS A STRANGE SENSATION IN THE BACK OF HIS HEAD. A REPOSITION SURGERY WAS DONE ON (B)(6) 2018 AND THE SURGEON CONFIRMED 6 EXTRA-COCHLEA ELECTRODE CONTACTS. IN SITU TESTING WAS PERFORMED ON ALL ELECTRODE CONTRACTS AND WAS WITHIN NORMAL LIMITS.

    Description of Event or Problem · 0

    PATIENT HAS A KNOWN HISTORY OF MIGRATION SINCE (B)(6) 2017. MIGRATION WAS FOLLOWING AN EVENT (COLD AND HOSPITALIZATION AND PLACEMENT OF A PIC LINE) AND THEREFORE 6 CHANNELS WERE DISABLED BECAUSE THEY WERE OUT OF COCHLEA. SINCE (B)(6) 2017 PATIENT IS NOT USING THE DEVICE ANYMORE. THE SURGEON IS CONSIDERING A RE-IMPLANTATION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594065 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 83 YR Required Intervention