BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1893464 · Received November 8, 2010

    Report

    Report Number
    2124215-2010-21735
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    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 INSPECTION NOTED THAT THERE WERE SETSCREW MARKS ON ALL TERMINAL CONNECTORS. 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 OF LOSS OF CAPTURE AND AN INCREASE IN PACING IMPEDANCE MEASUREMENTS. DETAILED ANALYSIS FOUND THIS LEAD TO BE ELECTRICALLY CONTINUOUS AND DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A REPOSITIONING PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH LOSS OF CAPTURE AT MAXIMUM OUTPUTS. THIS LEAD WAS IMPLANTED USING THE CEPHALICE VEIN METHOD. IN ADDITION, THE PACING IMPEDANCE MEASUREMENTS INCREASED FROM 363 TO 1812 OHMS AND THE PATIENT REPORTED FEELING STIMULATION UNDER THE CHEST. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WAS SUCCESSFULLY REPLACED AND THEN SUBSEQUENTLY RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1