BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043191 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02861
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    November 1, 2012
    Report Date
    March 5, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS CONFIRMED THE INNER CONDUCTOR COIL WAS FRACTURED 47MM FROM THE TERMINAL PIN. THERE WAS A SHARP CURVE IN THE LEAD AND DEEP SURFACE ABRASIONS NOTED IN THE INSULATION OVER THIS AREA, AS WELL AS, ON THE TWO OTHER LEGS. DUE TO THE LOCATION AND TYPE OF DAMAGE THIS APPEARS CONSISTENT WITH A FATIGUE FRACTURE. THE FIELD ALLEGATION WAS CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE SHOCK LEAD IMPEDANCE ON THIS RIGHT VENTRICULAR (RV) LEAD MEASURED > 125 OHMS. THE FIELD REPRESENTATIVE SENT INFORMATION TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR REVIEW. IT APPEARED THAT IN (B)(6) 2012, THE DAILY MEASUREMENTS FOR THE SHOCK LEAD IMPEDANCES WERE VARIABLE WITH SOME OUT-OF-RANGE (OOR) READINGS NOTED, AND THAT THE SHOCK ELECTROGRAM (EGM) LOOKED UNUSUAL. CAPTURE, SENSING AND SENSING IMPEDANCES WERE NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT SURGICAL INTERVENTION WAS PERFORMED DUE TO THE HIGH SHOCK LEAD IMPEDANCE READINGS, AND THIS LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146929 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R 4136| 4591| 0184| N119