BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION¿ IMPLANT

    MDR report key: 20328425 · Received September 27, 2024

    Report

    Report Number
    3006556115-2024-01449
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 21, 2024
    Report Date
    September 6, 2024
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D.9. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE EXTERNAL VISUAL INSPECTION REVEALED A SEVERED ELECTRODE. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. THE DEVICE PASSED THE PHOTOGRAPHIC IMAGING INSPECTION. SYSTEM LOCK WAS VERIFIED. THE ELECTRODE CONDITION PREVENTED AN ELECTRICAL TEST FROM BEING PERFORMED. THE DEVICE PASSED THE ELECTRICAL TEST PERFORMED. THE DEVICE PASSED THE MECHANICAL TESTS PERFORMED. THE INTERNAL VISUAL INSPECTION REVEALED A CRACKED CONDUCTIVE EPOXY ON THE KOVAR TAB. THE REPORTED COMPLAINT OF LOSS OF LOCK WAS CONFIRMED DURING THE ANALYSIS OF THIS DEVICE. INTERNAL VISUAL INSPECTION REVEALED A CRACK ON THE CONDUCTIVE EPOXY OF THE KOVAR TAB, WHICH IS BELIEVED TO BE RELATED TO THE LOSS OF LOCK. THIS OLDER DEVICE CONFIGURATION IS NOT CURRENTLY MANUFACTURED. THIS IS THE FINAL REPORT. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION H.10. ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE EXTERNAL VISUAL INSPECTION REVEALED A SEVERED ELECTRODE. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. THE DEVICE PASSED THE PHOTOGRAPHIC IMAGING INSPECTION. SYSTEM LOCK WAS VERIFIED. THE ELECTRODE CONDITION PREVENTED AN ELECTRICAL TEST FROM BEING PERFORMED. THE DEVICE PASSED SOME OF THE ELECTRICAL TEST PERFORMED. THE DEVICE PASSED THE MECHANICAL TESTS PERFORMED. THE INTERNAL VISUAL INSPECTION REVEALED A CRACKED CONDUCTIVE EPOXY ON THE KOVAR TAB. THE REPORTED COMPLAINT OF LOSS OF LOCK WAS CONFIRMED DURING THE ANALYSIS OF THIS DEVICE. INTERNAL VISUAL INSPECTION REVEALED A CRACK ON THE CONDUCTIVE EPOXY OF THE KOVAR TAB, WHICH IS BELIEVED TO BE RELATED TO THE LOSS OF LOCK. THIS OLDER DEVICE CONFIGURATION IS NOT CURRENTLY MANUFACTURED. THIS IS THE FINAL REPORT. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Description of Event or Problem · 0

    THE RECIPIENT REPORTEDLY EXPERIENCED LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED, HOWEVER THE ISSUE DID NOT RESOLVE. DEVICE TESTING COULD NOT BE COMPLETED DUE TO LOSS OF LOCK. 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
    1434288 CLARION¿ IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC AB-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female