BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 25259764 · Received May 22, 2026

    Report

    Report Number
    1644487-2026-10631
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 22, 2026
    Manufacturer
    HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE PATIENT WAS IN THE HOSPITAL FOR AN UNRELATED SURGERY IN PRE-OP THEIR HEARTRATE WAS OBSERVED TO BE AT 40 BEATS PER MINUTE. MEDICATION WAS ADMINISTERED TO SPEED UP THE HEART RATE, HOWEVER THE PHYSICIAN DID NOT HAVE THE TOOLS TO INTERROGATE THE DEVICE AT THAT TIME. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13928 PULSE GEN MODEL 1000 GENERATOR LYJ HOUSTON 1000 206525 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1