BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2041683 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01177
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A REVISION PROCEDURE, BOTH LEADS WERE CONFIRMED FRACTURED. THE RIGHT ATRIAL AND VENTRICULAR (RA; RV) LEADS WERE SURGICALLY ABANDONED. A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED AND RECONNECTED TO THE CHRONIC DEVICE. THE ATRIAL PORT OF THIS NEW DEVICE WAS PLUGGED WITH THE FRACTURED CHRONIC LEAD, WHICH WAS TURNED OFF. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention (B)(4)| (B)(4)| (B)(4)