BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2172800 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-10188
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 RIGHT VENTRICULAR (RV) LOSS OF CAPTURE (LOC) WAS OBSERVED UPON ELECTROGRAM REVIEW. RV PACING IMPEDANCE MEASUREMENTS DECREASED TO 320 OHMS AND PACING THRESHOLD MEASUREMENTS INCREASED TO 5.0 VOLTS AT 1.0 MS. ADDITIONALLY, PACING WAS NOT DELIVERED WHEN REQUIRED. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE RV LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R