BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.

    Recall: Z-0278-2014 · Reported November 20, 2013

    Enforcement

    Recall Number
    Z-0278-2014
    Event ID
    66506
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2013
    Initiation Date
    September 30, 2013
    Classification Date
    November 14, 2013
    Termination Date
    November 20, 2015
    Address
    7000 Central Ave NE, Minneapolis, MN, 55432-3568, United States

    Description

    Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.

    Reason

    Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR).

    Code Info

    all serial numbers

    Distribution

    Worldwide distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.

    Quantity

    64,163