BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 3211563 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08438
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    February 13, 2013
    Report Date
    May 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED AND THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. 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 ROUTINE IN-CLINIC FOLLOW UP, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS. REVIEW OF STORED DEVICE MEMORY REVEALED THAT THE OUT OF RANGE MEASUREMENTS BEGAN THREE MONTHS AGO. LOW AND HIGH ENERGY SHOCKS WERE DELIVERED TO ASSESS THE SYSTEM AND SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED TO BE WITHIN NORMAL LIMITS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED REPLACEMENT OF THE LEAD DUE TO INTERMITTENT OUT OF RANGE MEASUREMENTS. AN INVASIVE PROCEDURE WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308900 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0135

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 1861| 1782| 1705| 4053| 0074| N119| H170| 0135| 4194