BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 1953655 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24120
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 8, 2010
    Report Date
    January 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD INDICATED THAT THE LEAD WAS SEVERED 245 MILLIMETERS FROM THE TERMINAL PIN, ONLY THE PROXIMAL SECTION WAS RETURNED. THERE WERE SETSCREW MARKS NOTED ON THE LEAD TERMINALS AND BLOOD/BODY FLUIDS WAS NOTED IN THE LUMENS. RESISTANCE AND PRESSURE TEST WERE USED TO TEST ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED BY ANALYSIS OF THE RETURNED LEAD SEGMENT.

    Additional Manufacturer Narrative · 1

    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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS ELECTIVELY REPLACED AND SURGICALLY ABANDONED DUE TO OVERSENSING OF NOISE ON THE PACE/SENSE CHANNEL CAUSING INTERMITTENT PACING INHIBITION GREATER THAN TWO SECONDS AND INAPPROPRIATE CLASSIFICATION OF VF. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD NO ADVERSE EFFECTS AS A RESULT OF THE PACING INHIBITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0155

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention T165| 1861| 4087| 0180| 0155| E102