BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2911326 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15968
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 20, 2012
    Report Date
    December 17, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD FOUND THAT THE HELIX MECHANISM WAS RETRACTED AND DRIED BLOOD WAS NOTED IN THE HELIX HOUSING. ADDITIONALLY, THE INSULATION BETWEEN THE ANODE RING AND HELIX WAS TWISTED. A LABORATORY TECHNICIAN TESTED THE HELIX MECHANISM AND FOUND IT WAS NONFUNCTIONAL, CONFIRMING THE CLINICAL OBSERVATION. BASED UPON THE CLINICAL OBSERVATIONS AND THE LABORATORY FINDINGS, WE BELIEVE THAT BODY FLUID AND/OR TISSUE INSIDE THE HELIX HOUSING CAUSED THE IRREGULARITY IN HELIX FUNCTION. MOST LIKELY DUE TO DRIED BODY FLUID IN THE MECHANISM. ALSO, THE TWISTED INSULATION BETWEEN THE ANODE RING AND THE HELIX WAS FELT TO BE MOST LIKELY DUE TO OVERTORQUING THE HELIX.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS RIGHT VENTRICULAR (RV) LEAD, THE LEAD WAS SUCCESSFULLY PLACED IN THE HIGH SEPTUM. AFTER POCKET CLOSURE, R-WAVE MEASUREMENTS DROPPED TO THREE MILLIVOLTS. THE POCKET WAS REOPENED AND THE LEAD WAS REPOSITIONED TO THE MID-SEPTUM, WHERE R-WAVE MEASUREMENTS WERE OBSERVED TO BE 12 MILLIVOLTS. SUBSEQUENTLY, R-WAVE MEASUREMENTS AGAIN DROPPED TO THREE MILLIVOLTS. ANOTHER ATTEMPT WAS MADE TO REPOSITION THE LEAD, HOWEVER, THE HELIX MECHANISM WOULD NOT EXTEND. THE LEAD WAS REMOVED AND A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16520 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R K173| S202| 4470| 4088