BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOM STIMULATOR

    MDR report key: 22633791 · Received July 28, 2025

    Report

    Report Number
    MW5173434
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Report Date
    January 14, 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 (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
    1256829 BLOOM STIMULATOR GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE (FOR ELECTROPHYSIOLOGICAL ST JOQ FISCHER MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown