BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE

    MDR report key: 8881870 · Received August 11, 2019

    Report

    Report Number
    6000034-2019-01396
    Event Type
    Injury
    Date Received
    August 11, 2019
    Report Date
    August 15, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502032599
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE PREVIOUS OR INITIAL MDR SUBMITTED ON AUGUST 12, 2019 WAS FILED INADVERTENTLY. NO DEVICE MALFUNCTION/ EXPLANTATION OR SERIOUS INJURY HAS OCCURRED. THIS REPORT IS SUBMITTED SEPTEMBER 09, 2019.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON AUGUST 12, 2019.

    Description of Event or Problem · 1

    PER THE CLINIC, THE RECIPIENT HAD A MRI ON (B)(6) 2019. NO PAIN AND NO REACTION WERE REPORTED DURING THE MRI. HOWEVER, A WEEK LATER IT WAS DISCOVERED THE MAGNET OF THE INTERNAL DEVICE WAS REVERSED. THE IMPLANTED DEVICE REMAINS. A REVERSE POLARITY MAGNET HAS BEEN ORDERED FOR THE RECIPIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675777 NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI522 NI 09321502032599

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention