BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 7247023 · Received February 7, 2018

    Report

    Report Number
    9710014-2018-00096
    Event Type
    Injury
    Date Received
    February 7, 2018
    Date of Event
    January 22, 2018
    Report Date
    November 13, 2018
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 RECIPIENT REPORTED HAVING SEVERE MIGRAINES. REPORTEDLY, A FULL INSERTION WAS NOT ACHIEVED DURING IMPLANTATION DUE TO RESISTANCE AND TWO ELECTRODE CHANNELS REMAINED EXTRA-COCHLEAR. RE-IMPLANTATION IS SCHEDULED.

    Additional Manufacturer Narrative · 1

    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH AND VIBRANT MED-EL SUBMIT MDR REPORTS ON BEHALF OF MED-EL CORPORATION (EXEMPTION NUMBER E2015033). CONCLUSION: DEVICE INVESTIGATIONS DID NOT REVEAL ANY DEVICE DEFECT WHICH IS EXPECTED TO HAVE BEEN PRESENT WHILST IMPLANTED OR WOULD EXPLAIN THE REPORTED PROBLEMS. DAMAGES FOUND DURING DEVICE INVESTIGATION ARE MOST LIKELY RELATED TO THE EXPLANTATION SURGERY. BASED ON THE RECEIVED INFORMATION, THE RECIPIENT WAS EXPLANTED DUE TO MIGRAINES WHICH OCCURED AFTER IMPLANTATION. HOWEVER, THE USER IS AFFECTED BY MENIERE'S DISEASE, WHICH MIGHT HAVE CONTRIBUTED TO POTENTIAL POST-IMPLANT HYDROPS, CAUSING THE OBSERVED SYMPTOMS. REPORTEDLY, AFTER REIMPLANTATION SURGERY THESE SYMPTOMS COULD BE RELIEVED, POSSIBLY DUE TO DECOMPRESSION OF THE PERILYMPHATIC SPACE. FURTHER, RECIPIENTS WITH THIS DISEASE MAY HAVE FLUCTUATIONS OF PERFORMANCE WITH COCHLEAR IMPLANT AND HEARING SENSITIVITY. REGARDING THE TWO ELECTRODE CONTACTS OUT OF THE COCHLEA SINCE IMPLANTATION, THEY COULD HAVE ALSO CONTRIBUTED TO THE POOR BENEFIT. FURTHERMORE IN SITU MEASUREMENTS SHOWED ONE CHANNEL WITH HIGH IMPEDANCE DUE TO UNDETERMINED REASONS, WHICH COULD NOT BE REPRODUCED DURING INVESTIGATION. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE RECIPIENT REPORTED HAVING SEVERE MIGRAINES THAT STARTED AFTER IMPLANTATION. PERFORMANCE WAS ALSO UNSATISFACTORY AND RECIPIENT DID NOT HAVE MUCH SPEECH RECOGNITION. REPORTEDLY, A FULL INSERTION WAS NOT ACHIEVED DURING IMPLANTATION DUE TO RESISTANCE AND TWO ELECTRODE CHANNELS WERE LEFT EXTRA-COCHLEAR. THE RECIPIENT WAS RE-IMPLANTED WITH A SHORTER (+FLEX24) ELECTRODE ARRAY. A SIGNIFICANT AMOUNT OF LIQUID DRAINED FROM THE COCHLEA WHEN THE IMPLANT WAS REMOVED. PER DEVICE EXPLANTATION REPORT, 2 CHANNELS WERE CONFIRMED EXTRA-COCHLEAR. A FULL INSERTION OF THE NEW DEVICE WAS ACHIEVED AND IN SITU MEASUREMENTS SHOWED NORMAL IMPEDANCES ON ALL CHANNELS. THE RECIPIENT WAS ACTIVATED WITH THE NEW DEVICE. AUDITORY PERCEPT WAS PRESENT FOR ALL CHANNELS AND THERE WAS NO PAIN WITH STIMULATION ON ANY OF THE CHANNELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92781 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1200 SYNCHRONY

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention