BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTTOUCH

    MDR report key: 19341049 · Received May 17, 2024

    Report

    Report Number
    1000165971-2024-00413
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    May 2, 2024
    Report Date
    October 23, 2024
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    KRG
    UDI-DI
    08031527020730
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEPTION OF THE SUBJECT DEVICE, THE REPORTED ISSUE COULD NOT REPRODUCED. THE DATE OF THE FOLLOW-UP AND THE TYPE OF IMPLANTABLE DEVICE WHEN THE ISSUE OCCURRED WERE JOT PROVIDED. THE PROGRAMMER WILL FOLLOW THE NORMAL WORKFLOW OF REPAIR AND WILL RETURN BACK TO THE FIELD. NO GENERAL MALFUNCTION IS SUSPECTED ON THE DEVICE. THIS CASE IS RETAINED AND UTILIZED FOR TRENDING PURPOSES.

    Description of Event or Problem · 0

    THE PHYSICIAN HAD FREEZES OF THE SCREEN DURING SEVERAL FOLLOW-UPS.

    Description of Event or Problem · 0

    THE PHYSICIAN HAD FREEZES OF THE SCREEN DURING SEVERAL FOLLOW-UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520873 SMARTTOUCH PROGRAMMER, PACEMAKER KRG MICROPORT CRM S.R.L. SMARTTOUCH SOFTWARES MODULES 08031527020730

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown