BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1952841 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-24366
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    January 12, 2011
    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

    THE LEAD WAS RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    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. VISUAL INSPECTION OF THE LEAD BODY NOTED SLIGHT BUNCHING OF THE POLYURETHANE INSULATION IN SEVERAL PLACES NEAR THE TERMINAL PIN. THE BUNCHING IS NOT LIKELY TO HAVE CONTRIBUTED TO THE CLINICAL OBSERVATIONS. INSPECTIONS OF THE TERMINAL PIN ASSEMBLY AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS OF DISLODGEMENT OR HIGH IMPEDANCE.

    Additional Manufacturer Narrative · 1

    AN ATTEMPT WAS MADE TO DETERMIN WHETHER THE EXPLANTED LEAD WILL BE RETURNED FOR ANALYSIS, HOWEVER, NO FURTHER INFORMATION WAS RECEIVED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD A PACING IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS. AN X-RAY SHOWED THE LEAD HELIX WAS NOT COMPLETELY EXTENDED, AND THE LEAD APPEARED STRETCHED. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT STATED THE X-RAYS SHOWED THE LEAD HAD DISLODGED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention