BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION¿ IMPLANT

    MDR report key: 7675723 · Received July 10, 2018

    Report

    Report Number
    3006556115-2018-00301
    Event Type
    Malfunction
    Date Received
    July 10, 2018
    Date of Event
    June 18, 2018
    Report Date
    June 18, 2018
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED THE EXTERNAL VISUAL AND PHOTOGRAPHIC IMAGING INSPECTIONS. SYSTEM LOCK COULD NOT BE OBTAINED AT ANY SPACING. THE NO LOCK CONDITION PREVENTED SOME OF THE ELECTRICAL TESTS FROM BEING PERFORMED. THE DEVICE PASSED SOME OF THE ELECTRICAL TESTS PERFORMED. THE DEVICE FAILED THE RESIDUAL GAS ANALYSIS TEST. THE INTERNAL VISUAL INSPECTION REVEALED THAT A RESISTOR HAD A CORRODED TRACE. IN ADDITION, A BROKEN SUBSTRATE WAS OBSERVED, WHICH WAS INDUCED DURING THE FAILURE ANALYSIS PROCESS. IT IS BELIEVED THAT THE FAILURE OF THIS IMPLANTABLE COCHLEAR STIMULATOR (ICS) DEVICE WAS CAUSED BY A LOSS OF HERMETIC SEAL. THIS IS CONCLUDED FROM THE RESIDUAL GAS ANALYSIS DATA. MOISTURE ADMITTED INTO THIS DEVICE THROUGH THIS LEAK RESULTED IN THE CORROSION OF THE RESISTIVE FILM MATERIAL AND THE SHIFT IN RESISTANCE VALUE OF A RESISTOR. THIS ULTIMATELY CAUSED THE DEVICE TO CEASE FUNCTIONING. THIS OLDER DEVICE CONFIGURATION IS NO LONGER MANUFACTURED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE RECIPIENT REPORTEDLY EXPERIENCED LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518447 CLARION¿ IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC MMT-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR