BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4150867 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-16334
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS NOT EXPECTED TO BE RETURNED. 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 RECEIVED INFORMATION THAT DURING SYSTEM UPGRADE, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM EXHIBITED LOSS OF CAPTURE (LOC) AND WAS SUSPECTED TO BE DUE TO A FRACTURE ON THE LEAD'S PACING PART. THIS RV LEAD WAS SURGICALLY ABANDONED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NO CONCLUSIVE CAUSE OF THE OBSERVATION WAS IDENTIFIED AND THE FRACTURE WAS NOT CONFIRMED. THIS RV LEAD IS NO LONGER IN SERVICE. THE CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633575 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R 4470| N140| 4593| 0293| 4543| E140