BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 6763277 · Received August 3, 2017

    Report

    Report Number
    9710014-2017-00645
    Event Type
    Injury
    Date Received
    August 3, 2017
    Report Date
    November 20, 2017
    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

    (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 (B)(4). (EXEMPTION NUMBER E2015033). CONCLUSION: ACCORDING TO THE RECIPIENT'S REPORT, THE DEVICE WAS EXPLANTED DUE TO PARTIAL MIGRATION OUT OF COCHLEA OF THE ACTIVE ELECTRODE ARRAY. REPORTEDLY, A FULL INSERTION WAS ACHIEVED AT INITIAL IMPLANTATION. FURTHERMORE, DURING THE REVISION SURGERY FIBROTIC TISSUE WAS ENCOUNTERED, WHICH HAD ENCOMPASSED THE ELECTRODE LEAD. THE DAMAGES FOUND ON THE ELECTRODE ARRAY CONTACTS DURING DEVICE INVESTIGATION ARE MOST LIKELY RELATED TO THE REPORTED MULTIPLE REINSERTION ATTEMPTS. NO OTHER DAMAGES HAVE BEEN IDENTIFIED AND DEVICE WORKS WITHIN SPECIFICATIONS DURING INVESTIGATIONS. THE INVESTIGATION RESULTS APPEAR TO MATCH THE PROBLEMS MENTIONED IN THE PATIENT REPORT. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    AT ACTIVATION THE PATIENT HAD NO AUDITORY PERCEPTION ON CHANNELS 6-12.

    Description of Event or Problem · 0

    AT ACTIVATION THE RECIPIENT HAD NO AUDITORY PERCEPTION ON CHANNELS 6-12. THE CHANNELS WERE DISABLED DUE TO LACK OF AUDITORY PERCEPT AND THE USER WAS GIVEN PROGRESSIVE MAPS. NO TRAUMA, ACCIDENT, CHANGE IN HEALTH OR COCHLEAR ANOMALY WAS REPORTED. ON (B)(6)2017, THE SURGEON ATTEMPTED TO RE-INSERT THE ACTIVE ELECTRODE ARRAY. AFTER MULTIPLE ATTEMPTS TO REINSERT, DAMAGED CONTACTS ON THE ELECTRODE ARRAY WERE VISUALIZED. THE DECISION WAS MADE TO RE-IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546005 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1200 SYNCHRONY

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention