BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHYTHMIA HDX

    MDR report key: 14435871 · Received May 19, 2022

    Report

    Report Number
    2134265-2022-05663
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    April 24, 2022
    Report Date
    May 18, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    08714729938712
    PMA / PMN Number
    K162793
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    POST ABLATION PROCEDURE A RHYTHMIA HDX MAPPING SYSTEM WAS SELECTED FOR USE. THE PHYSICIAN NOTICED INTERFERENCE AFTER ABLATION WAS COMPLETED, AND THE PROCEDURE WAS ULTIMATELY NOT COMPLETED DUE TO THE INCIDENT. THE PATIENT IS CURRENTLY IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393439 RHYTHMIA HDX COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC CORPORATION 87038 S0000906 08714729938712

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown