BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 1612189 · Received February 16, 2010

    Report

    Report Number
    2124215-2010-04160
    Event Type
    Injury
    Date Received
    February 16, 2010
    Date of Event
    January 28, 2010
    Report Date
    February 16, 2010
    Manufacturer
    GUIDANT CORP
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INFORMATION KNOWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED. AN ATTEMPT WAS MADE TO OBTAIN FURTHER ADDITIONAL INFORMATION WITHOUT SUCCESS. SAMARTIN RC, FERRE JM, DE CARRANZA MJ, MATEAS FR, GONZALEZ JL. (B) (6) PACEMAKER REGISTRY. 6TH OFFICIAL REPORT OF THE (B) (6) SOCIETY OF CARDIOLOGY WORKING GROUP ON CARDIAC PACING (2008). REV ESP CARDIOL. 2009 DEC; 62 (12): 1450-63.

    Description of Event or Problem · 1

    (B) (4) RECEIVED INFORMATION THAT DURING A LITERATURE REVIEW OF THE ATTACHED ARTICLE; ANALYSIS DATA WAS COMPARED ON PACEMAKER IMPLANTATIONS AND REPLACEMENTS REPORTED TO (B) (6) PACEMAKER REGISTRY DURING 2008. THE SUMMARY REVIEWED APPROXIMATELY THIRTY-SIX PERCENT OF ALL PACEMAKERS IMPLANTED. REASONS FOR LEAD REPLACEMENT INCLUDED OR ULCERATION, DISLODGEMENT, FRACTURE, INSULATION DAMAGE INCREASED THRESHOLD MEASUREMENTS. ADVERSE EVENTS INCLUDED SYNCOPE, DIZZINESS, DYSPNEA OR SIGNS OF HEART FAILURE AND BRADYCARDIA. IT IS UNK WHETHER THE REPORTED INFORMATION WAS RELATED TO A (B) (4) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE DXY GUIDANT CORP BRADY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening