BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780989 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13262
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 22, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 ANALYSIS NOTED THE PROXIMAL SPRING WAS STRETCHED AND SOME GORE COATING HAD BEEN TORN. THE HELIX WAS FULLY RETRACTED AND INTACT WITH NO SIGNS OF PHYSICAL DAMAGE. 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. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES IN REGARDS TO THE ALLEGATION.

    Additional Manufacturer Narrative · 1

    TO DATE, THIS RIGHT VENTRICULAR (RV) LEAD HAS NOT BEEN RECEIVED BY BOSTON SCIENTIFIC. UPON RECEIPT, THIS RV LEAD WILL UNDERGO A DETAILED LABORATORY ANALYSIS IN AN EFFORT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE SENSING DECREASED ON THIS RIGHT VENTRICULAR (RV) LEAD FROM 25MV TO 1.4MV. THE LEAD DISLODGEMENT WAS DETECTED BY X-RAY. A REVISION PROCEDURE ENSUED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R