BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROMA3

    MDR report key: 946610 · Received November 7, 2007

    Report

    Report Number
    MW5004370
    Event Type
    Other
    Date Received
    November 7, 2007
    Date of Event
    October 30, 2007
    Report Date
    November 7, 2007
    Manufacturer
    IVIVI TECHNOLOGIES
    Product Code
    ILX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRIAL OF ROMA3 BY IVIVI IN PT WITH ELECTRONIC PACEMAKER. WE WERE TOLD THAT THE PT SELECTED BY THE CO REPRESENTATIVE WOULD BE ABLE TO USE THE DEVICE WITHOUT INTERFERENCE WITH HER PACEMAKER. WHEN THERAPY WAS INSTITUTED THE SECOND TIME THAT DAY, PT DEVELOPED SHOCK SENSATIONS AND MULTIPLE ELECTRICAL PACEMAKER ACTIVITY WAS SEEN ON EKG. UNIT WAS REMOVED AND PT HAS DONE WELL. THERE SEEMS TO BE NO PERMANENT DAMAGE. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: INCREASED WOUND HEALING. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROMA3 NONE ILX IVIVI TECHNOLOGIES ROMA *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other