BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 4930943 · Received July 20, 2015

    Report

    Report Number
    3006556115-2015-00324
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    July 9, 2015
    Report Date
    June 29, 2015
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE RECIPIENT CONTINUES TO EXPERIENCE PAIN; HOWEVER, THE RECIPIENT SURGEON CONFIRMED THAT THE PAIN IS NOT RELATED TO THE DEVICE. THE EXTERNAL VISUAL INSPECTION OF THE DEVICE REVEALED TOOLS MARKS AND DENTS ON THE BOTTOM COVER, AND THE ELECTRODE WAS SEVERED ALONG THE LEAD PRIOR TO RECEIPT. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. THE DEVICE PASSED THE PHOTOGRAPHIC IMAGING INSPECTION. SYSTEM LOCK COULD NOT BE OBTAINED AT ANY SPACING. THIS IS BELIEVED TO BE DUE TO THE USE OF MONOPOLAR CAUTERY. THE NO LOCK CONDITION PREVENTED ONE OF THE ELECTRICAL TESTS FROM BEING PERFORMED. THE DEVICE PASSED THE ELECTRICAL TESTS PERFORMED. RESIDUAL GAS ANALYSIS RESULT REVEALED PRESENCE OF NITROGEN ABOVE THE LIMIT. SCANNING ELECTRON MICROSCOPY ANALYSIS OF SEAM WELD AND VENT HOLE REVEALED A CRACK ON THE SEAM WELD. THIS DEVICE MALFUNCTION DUE TO THE REPORTED USE OF MONOPOLAR ELECTROCAUTERY DURING EXPLANT SURGERY. IN ADDITION, THIS DEVICE HAD NITROGEN THAT EXCEEDED THE TEST LIMIT. BASED ON AN ASSESSMENT OF THE HELIUM LEAK TEST DATA, IT IS BELIEVED THAT THIS DEVICE WAS NON-HERMETIC. THE ROOT CAUSE OF THE EXCESSIVE NITROGEN WAS A LEAK THROUGH THE CRACK IN THE SEAM WELD CAUSED DURING EXPLANT SURGERY. DUE TO THE PRESENCE OF MOISTURE GETTER, NO SIGNS WERE OBSERVED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE RECIPIENT WAS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES AND PAIN, WITH AND WITHOUT DEVICE USE. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS NOT REIMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468833 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention