BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR

    MDR report key: 21072165 · Received January 3, 2025

    Report

    Report Number
    2029046-2025-00033
    Event Type
    Injury
    Date Received
    January 3, 2025
    Date of Event
    December 9, 2024
    Report Date
    January 3, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION, AND THE PATIENT EXPERIENCED COMPLETE HEART BLOCK THAT REQUIRED PACEMAKER IMPLANTATION. A COMPLETE HEART BLOCK WAS NOTICED WHEN ABLATING WITH 4 MM CATHETER. THEY IMMEDIATELY STOPPED THE ABLATION AND MOVED THE 4MM CATHETER AWAY FROM THE AREA. THE PHYSICIAN WAITED ABOUT 15-20 MINUTES FOR THE HEART BLOCK TO RESOLVE. THE PHYSICIAN DECIDED TO CALL IN SURGICAL DEVICE SPECIALIST AND A PACEMAKER WAS IMPLANTED IN THE PATIENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670130 NAVISTAR CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNK_C3 WEBSTER QUADRAPOLAR WITH AUTO ID - FIXED| UNK_NGEN RF GENERATOR