BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3930011 · Received July 11, 2014

    Report

    Report Number
    2124215-2014-13689
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND RV LEAD EXHIBITED HIGH SHOCKING, LEAD IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONFIRMED THAT NO NOISE WAS OBSERVED AND WAS CONCERNED AS THERAPY COULD BE COMPROMISED. SUBSEQUENTLY, THE LEAD WAS SURGICALLY ABANDONED WHILE THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION (NBD). ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM WAS OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407747 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R 0292| 4554| N119| N140| 0184| 4469