BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHYTHMIA HDX

    MDR report key: 13078456 · Received December 23, 2021

    Report

    Report Number
    2134265-2021-16175
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Date of Event
    November 29, 2021
    Report Date
    December 23, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    DURING AN ABLATION TO TREAT LEFT ATRIAL FLUTTER A ULTRA ICE PLUS CATHETER AND RHYTHMIA MAPPING SYSTEM WERE SELECTED FOR USE. IT WAS REPORTED THAT POOR ULTRASOUND IMAGING/NOISE WAS OBSERVED DURING THE PROCEDURE. THE CATHETER WAS REPLACED, HOWEVER, THE TRANSEPTAL PUNCTURE WAS UNSUCCESSFUL. THE PROCEDURE WAS ABORTED. FURTHER TROUBLESHOOTING INDICATED THAT THE CAUSE OF THE NOISE WAS THE RHYTHMIA SIGNAL STATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1978280 RHYTHMIA HDX COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC CORPORATION 87038

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ULTRA ICE PLUS CATHETER