BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 11700950 · Received April 21, 2021

    Report

    Report Number
    9710452-2021-00025
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 21, 2021
    Product Code
    DXF
    UDI-DI
    00685447000204
    PMA / PMN Number
    K073326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT IMPACT OR CONSEQUENCE. BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE 20-MINUTE PROCEDURAL DELAY THAT OCCURRED. DHR REVIEW WAS COMPLETED FOR THE LOT IN QUESTION AND THE DEVICES FULFILLED ALL REQUIREMENTS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    THE NRG TRANSSEPTAL NEEDLE CAUSED AN ERROR CODE ON THE BAYLIS RADIOFREQUENCY PERFORATION GENERATOR WHEN RF DELIVERY WAS ATTEMPTED, RESULTING IN A 20-MINUTE PROCEDURAL DELAY. THE PROCEDURE WAS CARRIED OUT USING A NEW NRG TRANSSEPTAL NEEDLE. WHILE THERE WAS NO PATIENT INJURY REPORTED, BAYLIS MEDICAL COMPANY INC. HAS DECIDED TO REPORT THIS EVENT DUE TO THE 20-MINUTE PROCEDURAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598270 NRG TRANSSEPTAL NEEDLE RF TRANSSEPTAL NEEDLE DXF NRG-E-HF-71-C0 NGFB231120 00685447000204

    Patients

    Seq Age Sex Outcome Treatment
    1 Other