BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE PULSE GENERATOR

    MDR report key: 17333397 · Received July 14, 2023

    Report

    Report Number
    MW5119461
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    May 19, 2023
    Report Date
    July 6, 2023
    Manufacturer
    IMPULSE DYNAMICS (USA) INC.
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON THE (B)(6) 2023 TRANSMISSION THERE IS AN ATYPICAL DEFLECTION SEEN THAT IS NOT SENSED WHICH MAY BE AS A RESULT OF THE DEVICE OUTPUT OR LEADS HITTING TOGETHER IN THE RV. ON THE NEXT TRANSMISSION TODAY (B)(6) 2023 THE SIGNAL WAS NOT THERE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767410 IMPLANTABLE PULSE GENERATOR IMPLANTABLE PULSE GENERATOR LWP IMPULSE DYNAMICS (USA) INC. 10-B501-2-XX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown