BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1953734 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24565
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD TRIGGERED THE LEAD SAFETY SWITCH (LSS) ON THE DEVICE FOR OUT OF RANGE IMPEDANCE MEASUREMENTS. INAPPROPRIATE VENTRICULAR TACHYCARDIA ELECTROGRAMS WERE STORED IN THE DEVICE MEMORY ALONG WITH AN UNSUCCESSFUL THRESHOLD TEST DURING CLINIC FOLLOW UP DUE TO SOME ABNORMAL DEFLECTIONS DURING THE TEST. THE PATIENT WAS IN A MOTOR VEHICLE ACCIDENT TWO MONTHS AGO. THE IMPEDANCE MEASUREMENTS APPEARED STABLE, HOWEVER GIVEN THE INFORMATION, A LEAD FRACTURE WAS SUSPECTED. A LEAD REVISION WAS PERFORMED WERE THIS LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R 4087| 1298| 4086