BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHYTHMIA HDX

    MDR report key: 19762799 · Received July 17, 2024

    Report

    Report Number
    2124215-2024-44307
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 10, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    08714729938712
    PMA / PMN Number
    K162793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    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

    IT WAS REPORTED THAT DURING A PROCEDURE, A SIGNAL STATION WAS SELECTED FOR USE. DURING MAPPING, ORION WAS BLINKING FREQUENTLY. CONNECTION BOX AND CABLE WERE CONNECTED AGAIN, SIS WAS REBOOTED, AND CONSIDERING EXTERNAL FACTORS, BIS AND ESOPHAGEAL TEMPERATURE MONITOR POSITION WERE CHANGED, AND IT WAS DISCONNECTED, AND IT IMPROVED TEMPORARILY, BUT THE SAME SYMPTOMS OCCURRED AGAIN. PROCEDURE WAS CANCELLED/RESCHEDULED DUE TO THIS ISSUE. SHIPMENT FOR SIS REPLACEMENT WAS REQUESTED. MOREOVER, THE PHYSICIAN POINTED OUT THAT IT COULD NOT BE USED UNLESS EQUIPMENT INSPECTION AND SITE INVESTIGATION ARE COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, WHILE MAPPING WITH AN ORION MAPPING CATHETER, THE CATHETER WAS BLINKING FREQUENTLY. THE CONNECTION BOX AND CABLE WERE CONNECTED AGAIN, THE SIGNAL STATION WAS REBOOTED, AND EXTERNAL FACTORS WERE CONSIDERED. THE "BIS" AND ESOPHAGEAL TEMPERATURE MONITOR POSITIONS WERE CHANGED, AND IT WAS DISCONNECTED. THE ISSUE IMPROVED TEMPORARILY, BUT THE SAME SYMPTOMS OCCURRED AGAIN. AS A RESULT, THE PROCEDURE WAS CANCELLED/RESCHEDULED. A SIGNAL STATION REPLACEMENT OR IN-HOUSE SERVICING WAS REQUESTED. THE DEVICE REMAINS IN SERVICE AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144260 RHYTHMIA HDX COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC CORPORATION 87038 08714729938712

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown