BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3041317 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01400
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    February 1, 2013
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXPLANTED LEAD HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THE LEAD WILL UNDER GO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND SET SCREW MARKS ON THE TERMINAL PIN. IN ADDITION, THE PROXIMAL COIL WAS STRETCHED AND FLUID WAS NOTED IN THE HELIX. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES AS THE LEAD PASSED ALL ELECTRICAL TESTING.

    Description of Event or Problem · 1

    ==

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD EXPERIENCED A SHOCK AFTER A RUN OF VENTRICULAR TACHYCARDIA (VT). DURING A ROUTINE FOLLOW UP IT WAS NOTED THAT THE LEAD EXHIBITED NO CAPTURE FOR AN UNKNOWN DURATION AND HIGH THRESHOLDS. A REPLACEMENT PROCEDURE WAS SCHEDULED. BEFORE THE REPLACEMENT, IT WAS NOTED THAT THRESHOLD TESTING WAS PERFORMED FOR A SECOND TIME AND THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. A LEAD PERFORATION WAS SUSPECTED. THE LEAD WAS THEN EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143249 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI PLANT - ST. PAUL 0696

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R