BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO JEWEL

    MDR report key: 181307 · Received July 10, 1998

    Report

    Report Number
    2647346-1998-00108
    Event Type
    Injury
    Date Received
    July 10, 1998
    Date of Event
    March 18, 1998
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ICD DELIVERED 1ST CHARGE (15J) & 2ND (34J) BUT IMPEDANCE WAS INCREASED & FAILED TO DELIVER CHARGE ON NEXT 3 SHOCKS. PT EXTERNALLY RESCUED. TESTED AGAIN-IMPEDANCE OK W/DISD, BUT W/ICD, IMPEDANCE >200 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO JEWEL Implant IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7221E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 000 Other