BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 818690 · Received January 2, 2007

    Report

    Report Number
    9710014-2007-00030
    Event Type
    Malfunction
    Date Received
    January 2, 2007
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IMPLANTED WITH A STANDARD ELECTRODE 101734. ONLY 4 ELECTRODES CAUSED A HEARING SENSATION. THE TEAM AT THE CLINIC DECIDED TO REPLACE THE IMPLANT BECAUSE OF THE LIMITED PERFORMANCE. DURING REVISION SURGERY, THE SURGEON USED A M ELECTRODE - 103745, BUT WAS NOT ABLE TO INSERT IT SUFFICIENTLY. NO FURTHER INFORMATION ABOUT WHY HE WAS NOT ABLE TO INSERT THE M ELECTRODE. THE PATIENT WAS FINALLY IMPLANTED WITH 109073S IMPLANT. THE IMPLANT 103745 WAS IN TOUCH WITH HUMAN TISSUE. AT FIRST FITTING AND, THEN THE ONE MONTH FITTING WITH 109073S, THE BOY SHOWS RESPONSES ON THE 6 MOST APICAL CHANNELS ONLY. THE TEAM AT THE CLINIC IS CONSIDERING RE-IMPLANTATION DUE TO THE LIMITED PERFORMANCE OF THE PATIENT. THE PATIENT HAS A MONDINI MALFORMATION. NO FURTHER INFORMATION ABOUT THE GRADE. THERE IS NO INDICATION OF A TECHNICAL PROBLEM WITH THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH PULSAR *

    Patients

    Seq Age Sex Outcome Treatment
    1 *