BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES¿ 90K

    MDR report key: 20925689 · Received December 13, 2024

    Report

    Report Number
    3006556115-2024-01928
    Event Type
    Injury
    Date Received
    December 13, 2024
    Report Date
    December 9, 2024
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 RECIPIENT'S INFECTION HAS RESOLVED. THE RECIPIENT HAS RESUMED DEVICE USE. NO FURTHER DETAILS WILL BE PROVIDED. 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

    THE INFECTION IS NOT BELIEVED TO BE DEVICE RELATED. THE RECIPIENT REPORTEDLY UNDERWENT SURGERY TO CLEAR BIOFILM ON (B)(6) 2024. THE RECIPIENT HAS HEALED. THE RECIPIENT HAS RESUMED DEVICE USE. 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 REOCCURRING INFECTIONS. THE RECIPIENT PRESENTED WITH PAIN AND SWELLING. THE RECIPIENT WAS MEDICALLY TREATED (TYPE UNKNOWN) IN (B)(6) 2024. IN (B)(6) 2024 AN ULTRASOUND SONOGRAPHY (USG) WAS PERFORMED, AND SOME COLLECTION WAS OBSERVED. A SURGERY WAS PERFORMED TO CLEAR THE ACCUMULATION AND BIOFILM DEPOSITS WERE FOUND BOTH OVER AND UNDER THE INTERNAL IMPLANT. THESE COLLECTIONS WERE CLEARED WITH PRECAUTION. POST SURGERY, WHEN THE RECIPIENT WAS HEALED, IMPEDANCE AND NRI WERE MEASURED IN STERILE CONDITIONS. THE RESULTS REVEALED A SLIGHT INCREASE IN IMPEDANCES AND ABSENT NRI'S ESPECIALLY AT BASAL ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2417664 HIRES¿ 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention