BEUDAMED
    FDA Recall Open, Classified

    VISIONIST CRT-P Pacemaker

    Recall: Z-0365-2018 · Initiated December 7, 2017

    Recall

    Recall Number
    Z-0365-2018
    Event Number
    78787
    Firm
    Boston Scientific Corporation
    FEI Number
    2124215
    Product Code
    NKE
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    December 7, 2017
    Address
    4100 Hamline Ave N, Bldg 3, Saint Paul, MN, 55112-5700

    Description

    VISIONIST CRT-P Pacemaker

    Reason

    Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

    Action

    On December 19, 2017 the firm sent a letter to all their medical consignees stating the following: December 2017 Dear Doctor, Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude (Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV). Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems. Root Cause Investigation The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A. Engineering analysis and

    Distribution

    AK, AL, AR, AZ, CA , CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico Worldwide