BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4232394 · Received November 6, 2014

    Report

    Report Number
    2124215-2014-19527
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    May 12, 2006
    Report Date
    September 3, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS TRANSVENOUS DEFIBRILLATION LEAD WAS EXHIBITING PACING IMPEDANCE MEASUREMENTS THAT HAVE DECREASED FROM 700 OHMS AT IMPLANT TO 338 OHMS. SHOCK IMPEDANCE MEASUREMENTS HAVE DECREASED FROM 40 TO 31 OHMS AND MOST RECENTLY NOTED AS STABLE. ALL OTHER LEAD DIAGNOSTICS WERE REPORTED TO HAVE BEEN GOOD AND STABLE. IT WAS LATER NOTED THAT PACING IMPEDANCE MEASUREMENTS WERE LESS THAN 200 OHMS. AN INVASIVE PROCEDURE WAS PERFORMED. THROUGH PACING SYSTEM ANALYZER (PSA) TESTING IMPEDANCE MEASUREMENTS WERE FOUND TO BE 182 OHMS. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714705 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R 0158| 4244| 1861