BEUDAMED
    FDA Enforcement Class I Ongoing

    Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1

    Recall: Z-0810-2019 · Reported February 20, 2019

    Enforcement

    Recall Number
    Z-0810-2019
    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: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1

    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

    Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01, GTIN 00643169882959, 00763000109097, All Serial Numbers (b) Model Number SPDRL1, GTIN 00643169882966, 00763000109103, All Serial Numbers

    Distribution

    Wordlwide

    Quantity

    5392 units