BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210977 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07943
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 23, 2013
    Report Date
    June 6, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION NOTED EVIDENCE OF CALCIFICATION COVERING OVER MOST OF THE DISTAL POROUS MESH SCREEN PICO-TIP. ANALYSIS CONCLUDED THAT DEPENDING ON HOW MUCH CALCIFICATION WAS ON THE TIP BEFORE THE LEAD WAS EXPLANTED, THE IMPEDANCE MEASUREMENTS COULD HAVE BEEN AFFECTED.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD, IMPLANTED WITH A PACEMAKER EXHIBITED A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT RESULTING IN ACTIVATION OF THE LEAD SAFETY SWITCH (LSS) FEATURE. AN INVASIVE PROCEDURE WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311057 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0174

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R S602| 0174| 1688TC