BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2071445 · Received April 28, 2011

    Report

    Report Number
    2124215-2011-07478
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    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

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS REPORT, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED LOSS OF CAPTURE (LOC). THE LOCAL FIELD REPRESENTATIVE (FR) SENT IN A ELECTROGRAM (EGM) FOR TECHNICAL SERVICES (TS) TO REVIEW. TS BELIEVED THERE TO BE AN ISSUE WITH THE LEAD TO TISSUE INTERFACE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. A SAVE TO DISK WAS SENT IN FOR ANALYSIS. THERE WAS NO NOISE FOUND ON THE LEAD. THERE WERE NO ISSUES IDENTIFIED THROUGH ANALYSIS OF THE DISK. THE EGMS WERE REVIEWED AGAIN. IT WAS DETERMINED THAT THE LEAD TIP WAS NOT STABLE. THIS WAS REPRESENTED BY THE FACT THAT RV CAPTURE WAS SEEN AT HIGHER AND FASTER OUTPUTS VS A SLOWER RATE AT THE SAME OUTPUT. THE LEAD WILL CONTINUE TO BE MONITORED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0174

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization 4470| 0174| N119