BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSIGN AMPLIFIER FOR LABSYSTEM PRO EP RECORDING SYSTEM

    MDR report key: 10250605 · Received July 9, 2020

    Report

    Report Number
    2134265-2020-09114
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    June 15, 2020
    Report Date
    July 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    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 A CLEARSIGN AMPLIFIER FOR LABSYSTEM PRO EP RECORDING SYSTEM WAS SELECTED FOR A PROCEDURE. DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS SIGNAL NOISE. THE PROCEDURE WAS CANCELED DUE TO THIS NOISE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714149 CLEARSIGN AMPLIFIER FOR LABSYSTEM PRO EP RECORDING SYSTEM AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL DRQ BOSTON SCIENTIFIC CORPORATION 86620 1A485217

    Patients

    Seq Age Sex Outcome Treatment
    1