BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTTOUCH

    MDR report key: 20135452 · Received September 4, 2024

    Report

    Report Number
    1000165971-2024-00882
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 8, 2024
    Report Date
    October 25, 2024
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    KRG
    UDI-DI
    08031527021140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF PROVIDED DATA CONFIRMED THE REPORTED ISSUE ON (B)(6) 2024. THE PROVIDED EXPERT FILES SHOW THAT THE FOLLOW UP OF THE IMPLANTABLE PACEMAKER S/N (B)(6) STARTED ON (B)(6) AT 12:07 DID NOT END NORMALLY, AND THAT THE BATTERY WAS REMOVED AROUND 12:30. THE PROGRAMMER BECAME STUCK BEFORE THE END OF THE SESSION. THE ISSUE IS LINKED TO INTERNAL MANAGEMENT OF THE PROGRAMMER SOFTWARE (REPLY). THIS ISSUE WILL BE TRACED FOR FUTURE IMPROVEMENTS. NO GENERAL MALFUNCTION IS SUSPECTED ON THE SUBJECT DEVICE. THIS CASE IS RETAINED AND UTILIZED FOR TREND PURPOSES.

    Description of Event or Problem · 0

    REPORTEDLY, I RECEIVED A CALL TODAY FROM (B)(6). THEY USE A SMARTTOUCH PROGRAMMING SYSTEM WITH SOFTWARE VERSION 3.16. THERE WAS A SCREEN FREEZE ISSUE. THE PROBLEM WAS RESOLVED BY REMOVING THE BATTERY.

    Description of Event or Problem · 0

    REPORTEDLY, I RECEIVED A CALL TODAY FROM LKH GRAZ WEST. THEY USE A SMARTTOUCH PROGRAMMING SYSTEM WITH SOFTWARE VERSION 3.16. THERE WAS A SCREEN FREEZE ISSUE. THE PROBLEM WAS RESOLVED BY REMOVING THE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848314 SMARTTOUCH PROGRAMMER, PACEMAKER KRG MICROPORT CRM S.R.L. SMARTTOUCH SOFTWARES MODULES 08031527021140

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown