BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUPULSE¿ GENERATOR

    MDR report key: 23682872 · Received December 1, 2025

    Report

    Report Number
    2029046-2025-03951
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    October 31, 2025
    Report Date
    February 11, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    QZI
    UDI-DI
    10846835025231
    PMA / PMN Number
    P240006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO TRUPULSE¿ GENERATOR APPROVED UNDER P240006. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 15-JAN-2026, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION ABLATION PROCEDURE WITH A TRUPULSE¿ GENERATOR AND A BURNING SMELL WAS COMING FROM THE CATHETER INTERFACE UNIT. THERE WAS NO HARM ON THE PATIENT. THE PROCEDURE WAS COMPLETED. DEVICE EVALUATION DETAILS: TECHNICAL SERVICES PERFORMED REMOTE EVALUATION OF THE DEVICE. WORK ORDER (WO) SERVICE REPORT WAS SENT TO JOHNSON & JOHNSON MEDTECH FOR ANALYSIS. THE "BURNING ISSUE" WAS NOT DUPLICATED DURING THE EVALUATION: NO APPARENT BURN DAMAGE ON PORTS OR PLASTIC COVER WAS OBSERVED. THE CASE WAS COMPLETED AS NORMAL. IT WAS CONCLUDED THAT THE CONSOLE WAS DEFECTIVE AND IT HAD TO BE REPLACED TO MAKE SYSTEM OPERATIONAL. NO FURTHER EVALUATION ON THE REPLACED CONSOLE WAS PERFORMED AT THIS TIME. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER (B)(6), AND NO INTERNAL ACTIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS AS PART OF THE QUALITY PROCESS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION ABLATION PROCEDURE WITH A TRUPULSE¿ GENERATOR AND A BURNING SMELL WAS COMING FROM THE CATHETER INTERFACE UNIT. THERE WAS NO HARM ON THE PATIENT. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2443401 TRUPULSE¿ GENERATOR PERCUTANEOUS CARDIAC ABL CATH FOR TRTMT OF AFIB WITH IRREVERSIBLE ELECTR QZI BIOSENSE WEBSTER INC 10846835025231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown