BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 6137603 · Received December 1, 2016

    Report

    Report Number
    9710014-2016-00823
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 24, 2016
    Report Date
    February 28, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    CONCLUSION: INVESTIGATION RESULTS LEAD TO THE CONCLUSION THAT LIKELY THE DEVICE ELECTRONICS FAILED OVER TIME AFTER HUMIDITY INGRESS AT THE HOUSING BRAZE JOINT THROUGH MICRO-LEAKS. THE INVESTIGATION RESULTS APPEAR TO MATCH THE PROBLEMS MENTIONED IN THE PATIENT REPORT. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT ATTENDED THE CLINIC FOR AN UPGRADE. THE PATIENT HAD NOT BEEN WEARING THE OPUS 2 PROCESSOR FOR 3 MONTHS DUE TO BAD BATTERY LIFE OF LESS THAN 2 HOURS. ALL EXTERNAL EQUIPMENT WAS EXCHANGED BUT NO SOUND COULD BE PERCEIVED.

    Description of Event or Problem · 1

    THE PATIENT ATTENDED THE CLINIC FOR AN UPGRADE. THE PATIENT HAD NOT BEEN WEARING THE OPUS 2 PROCESSOR FOR 3 MONTHS DUE TO BAD BATTERY LIFE OF LESS THAN 2 HOURS AND LACK OF ACCESS TO SOUND. ALL EXTERNAL EQUIPMENT WAS EXCHANGED BUT NO SOUND COULD BE PERCEIVED. IN SITU MEASUREMENTS SHOWED A DEVICE MALFUNCTION. A DEVICE ASSESSMENT WILL TAKE PLACE. DEVICE ASSESSMENT CONFIRMED DEVICE MALFUNCTION. THE PATIENT HAS BEEN RE-IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787964 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH C40+

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention