BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1854005 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-18614
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 16, 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. 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 THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD REVEALED PACING IMPEDANCES GREATER THAN 2000 OHMS IN THE DAILY MEASUREMENTS. THE IMPEDANCES HAD VARIED BETWEEN 600-2000 OHMS. AT THE FOLLOW UP VISIT ON (B)(6), 2010, THE IMPEDANCE MEASUREMENT WAS 644 OHMS. ONE MONTH LATER, A REVISION PROCEDURE WAS PERFORMED. THE DECISION WAS MADE TO EXPLANT THE IMPLANTABLE CARDIAC DEFIBRILLATOR AND RIGHT VENTRICULAR LEAD AS A CONNECTION ISSUE, OR, A LEAD FRACTURE MAY HAVE CAUSED THE HIGH IMPEDANCE MEASUREMENTS NOTED CLINICALLY. BOTH THE DEVICE AND LEAD WERE REMOVED, REPLACED, AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 Life Threatening