BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE EL DR

    MDR report key: 7864038 · Received September 11, 2018

    Report

    Report Number
    7864038
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    May 10, 2018
    Report Date
    August 8, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LATITUDE ALERT FOR MV SENSOR NOISE ON RA CHANNEL RESULTING IN MODE SWITCHING, APPOINTMENT MADE FOR PATIENT TO COME INTO OFFICE. ABOUT 1.5 MONTHS LATER: TECH SERVICES WAS CONTACTED ABOUT NOISE, INSTRUCTED TO TURN OFF MV SENSOR AND CHANGE RA PACE IMPEDANCE TO UNIPOLAR PACE CONFIGURATION. ABOUT 1 MONTH LATER: PATIENT SEEN IN OFFICE, PROVOCATIVE MANEUVERS DONE TO RULE OUT LEAD ISSUE, NO NOISE OR ERRATIC IMPEDANCES WERE ABLE TO BE REPRODUCED. LOOKING BACK AT IMPEDANCES FOR PAST YEAR, NOTED RA IMPEDANCES TO BE QUITE ERRATIC 500-1600 OHMS. DID NOT MEET CRITERIA FOR ALERT SINCE WAS NEVER OUT OF RANGE. TECH SERVICES STATE THIS IS DUE TO BSC GENERATOR WITH COMPETITOR LEADS (MDT 5076), SPRING CONTACT ISSUE. MV SENSOR PROGRAMMED OFF AND RA PACE CONFIGURATION TO UNIPOLAR. MANUFACTURER RESPONSE FOR PACEMAKER, BOSTON SCIENTIFIC L321 ACCOLADE EL (PER SITE REPORTER). ISSUE IS RELATED TO USING A BSC GENERATOR WITH COMPETITOR LEADS, SPRING CONTACT ISSUE. CHANGE RA PACE POLARITY TO UNIPOLAR, MV SENSOR OFF AND CONTINUE TO MONITOR LEAD FOR FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704975 ACCOLADE EL DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L321

    Patients

    Seq Age Sex Outcome Treatment
    1 31390 DA