BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE

    MDR report key: 15812268 · Received November 17, 2022

    Report

    Report Number
    6000034-2022-03446
    Event Type
    Injury
    Date Received
    November 17, 2022
    Date of Event
    September 30, 2022
    Report Date
    December 12, 2022
    Manufacturer
    COCHLEAR LIMITED
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON NOVEMBER 17, 2022

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS REPORT ATTACHED. THIS REPORT IS SUBMITTED ON JANUARY 03, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT FELL DOWN FROM STAIRS (2-3 STEPS), HIT THE BTE SITE RESULTING IN AN INFECTION (PSEUDOMONAS AERUGINOSA ) (PUS DRAINAGE) AT THE IMPLANT SITE WHICH WAS TREATED WITH IV ANTIBIOTICS AND THERE WAS A REVISION SURGERY TO DRAIN THE PUS ON 2 OCCASIONS. THERE WAS A SKIN NECROSIS AND AN EXTRUSION OF THE RECEIVER/STIMULATOR. THE PATIENT WAS HOSPITALISED AND THE DEVICE WAS EXPLANTED ON (B)(6) 2022 AT WHICH TIME THE SKIN FLAP WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859867 NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LIMITED CI622 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Female Required Intervention| H