BEUDAMED
    FDA Enforcement Class I Ongoing

    Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1

    Recall: Z-0809-2019 · Reported February 20, 2019

    Enforcement

    Recall Number
    Z-0809-2019
    Event ID
    81945
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 20, 2019
    Initiation Date
    January 17, 2019
    Classification Date
    February 14, 2019
    Address
    8200 Coral Sea St Ne, N/A, Mounds View, MN, 55112-4391, United States

    Description

    Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1

    Reason

    A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality

    Code Info

    SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01, GTIN 00643169708914, All Serial Numbers (b) Model Number SEDR01, GTIN 00643169708877, 00643169708891, 00643169969780, All Serial Numbers (c) Model Number SEDRL1, GTIN 00643169708907, All Serial Numbers

    Distribution

    Wordlwide

    Quantity

    59232 units