BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3041153 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00731
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED AND IN USE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT A ROUTINE FOLLOW UP, INCREASED PACING THRESHOLDS WERE NOTED ON THIS RIGHT ATRIAL LEAD AND THE LEFT VENTRICULAR LEAD DUE TO SUSPECTED LEAD DISLODGEMENTS. A REVISION PROCEDURE WAS PERFORMED REVISE THE TWO LEADS. THE RIGHT ATRIAL LEAD WAS REPOSITIONED SUCCESSFULLY, HOWEVER THE LEFT VENTRICULAR LEAD WAS FULLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS OTHER THAN THE ADDITIONAL PROCEDURE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144174 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R