BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2041153 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01290
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BOSTON SCIENTIFIC (B)(4) SALES REPRESENTATIVE INDICATED THAT THIS RV LEAD WAS TO BE SURGICALLY REVISED. 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 THIS TRANSVENOUS RIGHT ATRIAL LEAD DID BECOME DISLODGED ONE DAY POST-IMPLANT. POOR SENSING AND LOSS OF CAPTURE WERE NOTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS BEYOND THE NEED FOR EARLY SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    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 69 YR 4063| 4285| 1270