BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 6676227 · Received June 29, 2017

    Report

    Report Number
    9710014-2017-00530
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    June 13, 2017
    Report Date
    October 18, 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.

    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: DEVICE INVESTIGATIONS DID NOT REVEAL ANY DEVICE DEFECT OR PROBLEM WHICH IS EXPECTED TO HAVE BEEN PRESENT WHILST IMPLANTED. DURING INVESTIGATION THE DEVICE OPERATES WITHIN SPECIFICATION AND THE OBSERVED DAMAGES ARE MOST LIKELY ATTRIBUTABLE TO THE EXPLANTATION SURGERY. BASED ON THE RECEIVED INFORMATION FROM THE FIELD, THE RECIPIENT WAS EXPLANTED DUE TO INTERMITTENT SOUND AND ELEVATED GROUND PATH IMPEDANCE, WHICH WAS LIKELY CAUSED BY AN AIR POCKET OR A BAD ELECTRICAL CONTACT TO CONNECTIVE TISSUE ABOVE THE REFERENCE ELECTRODE, AS MASSAGING THE IMPLANT SITE DID TEMPORARILY CHANGE THE VALUES. FURTHERMORE, ON THE DEVICE EXPLANTATION FORM IT IS STATED THAT THE IMPLANT HOUSING ROCKED SLIGHTLY FROM ITS ORIGINAL POSITION, WHICH MIGHT HAVE CONTRIBUTED TO THE OBSERVED SYMPTOMS. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    (B)(4) AND VIBRANT MED-EL SUBMIT MDR REPORTS ON BEHALF OF MED-EL CORPORATION (EXEMPTION NUMBER E2015033). ACCORDING TO THE AVAILABLE INFORMATION, THE OBSERVED SYMPTOMS ARE MOST LIKELY CAUSED BY AN AIR POCKET OR A BAD ELECTRICAL CONTACT TO CONNECTIVE TISSUE ABOVE THE REFERENCE ELECTRODE. MASSAGING THE IMPLANT SITE DID TEMPORARILY REDUCE THE GROUND PATH IMPEDANCE, BUT THIS VALUE WOULD INCREASE AGAIN WITHIN A FEW MINUTES. HOWEVER, TO DETERMINE AN EXACT ROOT CAUSE AN INVESTIGATION OF THE EXPLANTED DEVICE IS NECESSARY. RE-IMPLANTATION IS CONSIDERED BUT NOT SCHEDULED YET DUE TO OTHER MEDICAL CONDITIONS.

    Description of Event or Problem · 0

    THE PATIENT HAS BEEN EXPERIENCING INTERMITTENT SOUND WITH THE DEVICE FOR THE LAST 6 MONTHS.

    Description of Event or Problem · 0

    THE RECIPIENT EXPERIENCED INTERMITTENT SOUND WITH THE DEVICE FROM BEGINNING OF 2017. PRESSURE HAD TO BE APPLIED TO THE COIL TO HEAR BETTER THROUGHOUT THE DAY.THE RECIPIENT WAS RE-IMPLANTED ON (B)(4) 2018, WITH ANOTHER MANUFACTURER'S DEVICE.

    Description of Event or Problem · 0

    THE RECIPIENT EXPERIENCED INTERMITTENT SOUND WITH THE DEVICE FROM BEGINNING OF 2017. PRESSURE HAD TO BE APPLIED TO THE COIL TO HEAR BETTER THROUGHOUT THE DAY. THE USER WEARS A #4 STRENGTH MAGNET AND HAS GOOD RETENTION. A COMPRESSION BANDAGE WAS TRIED, BUT THIS DID NOT RESOLVE THE ISSUE OR AID IN HEARING BETTER WITH THE DEVICE. RE-IMPLANTATION WAS SCHEDULED FOR LATE AUGUST, HOWEVER IT WAS INDEFINITELY POSTPONED AS THE RECIPIENT HAS OTHER MEDICAL ISSUES TO ATTEND TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458666 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