BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2910092 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15244
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 7, 2012
    Report Date
    January 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. DRIED BLOOD WAS NOTED IN THE HELIX MECHANISM UP THROUGH THE LUMEN ALONG WITH IN THE HELIX MECHANISM. THE TERMINAL PIN WAS ALSO NOTED TO BE BENT. IN CONCLUSION THERE WAS NOTHING VISUALLY WRONG WITH THE LEAD THAT WOULD CAUSE A DISLODGMENT, AND NO FURTHER TESTING WAS PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SHORTLY AFTER THE IMPLANT OF THIS RIGHT VENTRICULAR LEAD, A DISLODGEMENT OCCURRED. A REVISION PROCEDURE WAS PERFORMED, HOWEVER THE LEAD COULD NOT BE REPOSITIONED, THEREFORE THE LEAD WAS 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
    19013 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R