BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR

    MDR report key: 22214726 · Received June 16, 2025

    Report

    Report Number
    MW5171541
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Report Date
    May 27, 2025
    Manufacturer
    FISCHER MEDICAL
    Product Code
    JOQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION PROCEDURE THE CONNECTED NON-(B)(6) STIMULATION GENERATOR WOULD RESET AFTER ABLATIONS. THE PROCEDURE WAS COMPLETED WITH BOTH ORIGINAL DEVICES WITH NO PATIENT COMPLICATIONS. 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
    33496 GENERATOR GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE JOQ FISCHER MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown