BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211546 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08947
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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. 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 NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LEAD WAS RETURNED AND IS CURRENTLY IN ANALYSIS. THIS REPORT WILL BE UPDATED ONCE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED OUT OF RANGE HIGH PACING IMPEDANCES DURING THE ATTEMPTED IMPLANT. THE PHYSICIAN ELECTED NOT TO IMPLANT THIS LEAD. THERE WERE NO ADVERSE PATIENT EFFECTS. A NEW LEAD WAS IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308692 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0285

    Patients

    Seq Age Sex Outcome Treatment
    1