BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHYTHMIA MAPPING SYSTEM

    MDR report key: 12583976 · Received October 6, 2021

    Report

    Report Number
    2134265-2021-12534
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    September 7, 2021
    Report Date
    October 6, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    PMA / PMN Number
    K130750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 ON SEPTEMBER 7TH, DURING PREPARATION FOR A PROCEDURE, IT WAS NOT POSSIBLE TO OBTAIN A PQI FOR THE BACKPATCH OF LESS THE 195. ULTRASOUND GEL PATCH WAS APPLIED BUT THE PROBLEM PERSISTED. IT WAS POSSIBLE TO OBTAIN A GOOD PQI VALUE WHEN PRESSURE WAS APPLIED TO THE PATCH, BUT THE PQI WOULD INCREASE ONCE THE PRESSURE WAS STOPPED. ANOTHER PATCH KIT WAS OPENED AND PLACED BUT IT DID NOT RESOLVE THE PROBLEM. THE PATCH CABLE WAS REPLACED BUT THE ISSUE CONTINUED. IT WAS NOTICED THAT THE PATIENT HAD A HIGH BODY MASS INDEX AND EXTREMELY DRY SKIN. THE PROCEDURE WAS CANCELLED. FOR THE NEXT PROCEDURE THE RHYTHMIA SYSTEM PERFORMED AS EXPECTED WITHOUT ISSUE. PATCH KIT WAS DISPOSED OF AND NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483971 RHYTHMIA MAPPING SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC CORPORATION 87025

    Patients

    Seq Age Sex Outcome Treatment
    1