BEUDAMED
    FDA Recall Terminated

    VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)

    Recall: Z-3258-2018 · Initiated September 10, 2018

    Recall

    Recall Number
    Z-3258-2018
    Event Number
    81001
    Firm
    Boston Scientific Corporation
    FEI Number
    2124215
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    September 10, 2018
    Terminated
    November 4, 2019
    Address
    4100 Hamline Ave N, Bldg 3, Saint Paul, MN, 55112-5700

    Description

    VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)

    Reason

    Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.

    Action

    On September 2018 Boston Scientific sent letters to their customers with the following information: Dear Doctor, Boston Scientific has identified a subset of approximately 2,900 active ACCOLADE", PROPONENT", and ESSENTIO" pacemakers and VISIONIST" and VALITUDE" cardiac resynchronization therapy pacemakers (CRT-Ps) with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion. There have been no reports of injury related to this behavior. You are receiving this letter because you or your center has implanted or follow one or more patients with a pacemaker in this subset. This device behavior can be identified via the regular pacemaker follow-up process, either in-clinic or through the LATITUDE" NXT Remote Patient Management System (LATITUDE). Therefore, a follow-up interval of no more than six (6) months is recommended and is consistent with existing international societal guidelines1. If accelerated depletion is suspected, Boston Scientific recommends consultation with Technical Services to review the pacemaker diagnostic data available from either a recent data upload in LATITUDE or a Save to Disk to confirm accelerated depletion and determine an appropriate timeframe for pacemaker replacement. Description The pacemaker manual describes how increases in pacing requirements or changes in programmed parameters may result in an expected longevity reduction and are considered normal battery depletion. However, hydrogen exposure within the pacemakers circuitry may compromise the electrical performance of low voltage capacitors causing current leakage and a moderate acceleration in the rate of battery depletion. Because this accelerated depletion does not occur rapidly, a follow-up interval of no more than six months is recommended. Boston Scientific has determined a liner component to be the source of hydrogen and identified a subset of previously distributed pacemakers that have an elevated potential for exh

    Distribution

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