BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIO XT PATCH

    MDR report key: 4898745 · Received July 2, 2015

    Report

    Report Number
    3007208829-2015-00003
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 5, 2015
    Report Date
    July 2, 2015
    Manufacturer
    IRHYTHM TECHNOLOGIES INC.
    Product Code
    DSH
    PMA / PMN Number
    K121319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CLINICAL FINDING AND MD NOTIFICATION OF ATRIAL TACHYCARDIA IS INCORRECT, AND APPARENTLY RESULTED FORM ISSUED WITH THE PATCH'S ON-BOARD CLOCK CAUSED BY AN INTERNAL FAULT. THIS UNCOMMON FAULT ALSO LIKELY CONTRIBUTED TO THE DEVICE'S PREMATURE SHUTDOWN DURING PATIENT WEAR.

    Description of Event or Problem · 1

    THE CLINICAL FINDING OF ATRIAL TACHYCARDIA WAS INCORRECTLY REPORTED TO THE PHYSICIAN AS A RESULT FORM AN INTERNAL FAULT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433110 ZIO XT PATCH ZIO PATCH DSH IRHYTHM TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR