BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHYTHMIA HDX

    MDR report key: 10747612 · Received October 28, 2020

    Report

    Report Number
    2134265-2020-14914
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 2, 2020
    Report Date
    October 28, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    08714729938682
    PMA / PMN Number
    K162793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT DUE TO A DEVICE ISSUE THE PROCEDURE WAS CANCELLED. DURING A PROCEDURE AN BACKPATCH WAS SELECTED FOR USE. WHEN THE PATIENT WAS REMOVED FROM THE PROCEDURE TABLE THERE WAS NO TRACKING OF THE CATHETER ON THE RHYTHMIA SYSTEM. THE RHYTHMIA MAPPING SPECIALIST (RMS) REBOOTED THE WORKSTATION AND SIGNAL STATION WHICH DID NOT RESOLVE THE ISSUE. REPLACING THE CABLE AND THE CATHETER ALSO DID NOT RESOLVE THE ISSUE. THEREFORE THE ABLATION PORTION OF THE PROCEDURE WAS CANCELLED AND THE PHYSICIAN PROCEEDED TO IMPLANT THE CARDIAC RESYNCHRONIZATION THERAPY DEVICE IN THE PATIENT SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. ADDITIONAL INFORMATION REVEALED THAT AFTER THE CASE THE RMS REPLACED THE BACKPATCH AND THE PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213899 RHYTHMIA HDX COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC CORPORATION 87042 1000001098 08714729938682

    Patients

    Seq Age Sex Outcome Treatment
    1