BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 6547082 · Received May 5, 2017

    Report

    Report Number
    9710014-2017-00361
    Event Type
    Injury
    Date Received
    May 5, 2017
    Date of Event
    March 9, 2017
    Report Date
    May 9, 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

    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 (B)(4). 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. BASED ON INFORMATION RECEIVED, THE DEVICE WAS FINALLY EXPLANTED FOR MEDICAL REASON, NAMELY AN INFECTION ON THE IMPLANT SITE THAT WAS OBSERVED DURING A DEVICE UNRELATED SURGERY TO DRAIN A SEROMA. THE LATTER, TOGETHER WITH THE OBSERVED AIR POCKET ON THE IMPLANT SITE, MIGHT HAVE CAUSED THE REPORTED DEVICE RETENTION PROBLEMS. FURTHER, ACCORDING TO IMAGING, THE PATIENT HAS AN INNER EAR MALFORMATION, WHICH COULD HAVE CONTRIBUTED TO THE REPORTED FACIAL NERVE STIMULATION AND LACK OF BENEFIT. ADDITIONALLY, IT IS SUSPECTED THAT THE ACTIVE ELECTRODE ARRAY MIGRATED OUT OF COCHLEA, POSSIBLY LEADING TO THE INCREASING NUMBER OF HI CHANNELS OBSERVED DURING IN-SITU MEASUREMENTS; HOWEVER THIS COULD BE CONFIRMED NEITHER BY DIAGNOSTIC IMAGING NOR AT EXPLANTATION SURGERY. FURTHER, THE ACTIVE ELECTRODE ARRAY, WHICH WAS LEFT IN PLACE DURING EXPLANTATION SURGERY, HAS BEEN RECEIVED AND INVESTIGATED OPTICALLY. SEVERAL ELECTRODE CONTACTS WERE FOUND TO BE DISPLACED, WHICH IS LIKELY RELATED TO THE REMOVAL SURGERY. THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    (B)(4). (EXEMPTION NUMBER E2015033). REPORTEDLY, THE PATIENT NEVER HAD ANY HEARING SENSATION, BUT EXPERIENCED ONLY FACIAL NERVE STIMULATION SINCE FIRST ACTIVATION. THE REPORTED LACK OF BENEFIT AND FACIAL NERVE STIMULATION ARE MOST LIKELY DUE TO DEVICE UNRELATED MEDICAL ISSUES, NAMELY AN INNER MALFORMATION, INCLUDING A COCHLEAR DYSPLASIA THAT WAS SHOWN BY DIAGNOSTIC IMAGING. FURTHER, THE REPORTED LONG-TERM AUDITORY DEPRIVATION LIKELY CONTRIBUTED TO THE LACK OF BENEFIT. ADDITIONALLY, A SEROMA NOT ASSOCIATED WITH INFECTION WAS REPORTED AROUND THE IMPLANT SITE, AND MIGHT HAVE CAUSED DEVICE RETENTION PROBLEMS. A SURGERY TO DRAIN THE FLUID WAS PERFORMED, DURING WHICH THE DEVICE WAS FOUND TO BE STABLE AND TO NOT HAVE MOVED. RECEIVED IN SITU MEASUREMENTS SHOW AN INCREASING NUMBER OF HI CHANNELS MOST LIKELY CAUSED BY MINUTE DEVICE MOBILITY. HOWEVER, TO DETERMINE AN EXACT ROOT CAUSE, A DEVICE INVESTIGATION OF THE EXPLANTED DEVICE IS NECESSARY.

    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

    PATIENT HAD NO AUDITORY PERCEPTION, FACIAL NERVE STIMULATION AND MINIMAL COIL RETENTION WITH THE DEVICE AT ACTIVATION. THE PATIENT IS THEREFORE NOT USING THE EXTERNAL PROCESSOR. ADDITIONAL INFORMATION RECEIVED STATED THAT THE USER HAS BEEN EXPLANTED. DURING SURGERY, SIGNIFICANT INFECTION AROUND THE PACKAGE AND POSSIBLY IN THE MASTOID AREA COULD BE OBSERVED SO IT WAS DECIDED TO REINSERT THE ARRAY AND LEAVE IT IN PLACE FOR LATER REIMPLANTATION. THE RECIPIENT WAS SUCCESFULLY REIMPLANTED WITH A NEW DEVICE ON (B)(6), 2017.

    Description of Event or Problem · 0

    PATIENT HAD NO AUDITORY PERCEPTION, FACIAL NERVE STIMULATION AND MINIMAL COIL RETENTION WITH THE DEVICE AT ACTIVATION. THE PATIENT IS THEREFORE NOT USING THE EXTERNAL PROCESSOR.PATIENT IS CONSIDERING RE-IMPLANTATION.

    Description of Event or Problem · 0

    PATIENT HAD NO AUDITORY PERCEPTION, FACIAL NERVE STIMULATION AND MINIMAL COIL RETENTION WITH THE DEVICE AT ACTIVATION. THE PATIENT IS THEREFORE NOT USING THE EXTERNAL PROCESSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328211 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1200 SYNCHRONY

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention