BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINIUM

    MDR report key: 20036276 · Received August 22, 2024

    Report

    Report Number
    1000165971-2024-00837
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 23, 2024
    Report Date
    August 22, 2024
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE REPORTED ISSUE IS LINKED TO THE SAME TICKET AS FOR VR, NOW BIV IS ONLY DISPLAYED FOR CRT DEVICES WITH V CHAMBER PROGRAMMED AT R+L OR L+R (REQ10141_DIC_SUM_0417 CREATED) -> BUG 4862: IN VR MODELS, INCORRECT MENTION OF A AND LV LEADS THIS BUG HAS BEEN CORRECTED AND WILL BE AVAILABLE ON FIELD WITH PLATINIUM 4.05.

    Description of Event or Problem · 0

    REPORTEDLY, A BIV% IS DISPLAYD ON A DOUBLE CHAMBER DEFIBRILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26824 PLATINIUM PROGRAMMER, PACEMAKER KRG MICROPORT CRM S.R.L. PLATINIUM DR 1510

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown