BEUDAMED
    FDA Recall Terminated

    VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872

    Recall: Z-1513-2008 · Initiated January 7, 2008

    Recall

    Recall Number
    Z-1513-2008
    Event Number
    46297
    Firm
    Boston Scientific CRM Corp
    FEI Number
    2124215
    Product Code
    LWP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 7, 2008
    Posted
    August 21, 2008
    Terminated
    December 30, 2008
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872

    Reason

    Repetitive mechanical stress applied to the titanium case can induce component damage and device malfunction in certain ICD and CRT-D devices implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. This update identifies additional VITALITY ICD

    Action

    An Urgent Medical Device Information Update to May 2006 Product Advisory, dated January 04, 2008, was sent to implanting physicians and physicians following implanted devices beginning Monday, January 07, 2008. The letter described a malfunction that can occur when the ICD is implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. The physicians were asked to review records to determine if an affected device was implanted subpectorally. An AP radiograph should be done to determine specific device orientation for subpectoral implants. If a subpectoral implant is in a susceptible orientation, consider repositioning or replacement for physically active patients who regularly need device therapy. Follow patients with susceptible devices at 3-month intervals.

    Distribution

    Nationwide and Worldwide: Bolivia, Panama, Iran, Saudi Arabia, Kuwait, United Arab Rep., Austria, Belgium, Cyrus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK, India, Australia, New Zealand, Malaysia, Singapore, Hong Kong, China, Israel, Turkey, Thailand, and Canada.

    Quantity

    BSC CRM estimates that the number of devices implanted in a susceptible orientation is likely less than 1% of the total active implants 25,000 (w.w.)