BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173246 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10784
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP APPOINTMENT APPROXIMATELY ONE WEEK POST IMPLANT THIS IMPLANTABLE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS EXHIBITING HIGH PACING THRESHOLD MEASUREMENTS AND LOSS OF CAPTURE AT 5.0 V AT 0.5 MS. INTRINSIC SENSING HAD ALSO DECREASED TO 2.8 MV. A REVISION PROCEDURE TOOK PLACE AND THE RV LEAD WAS SUCCESSFULLY REPOSITIONED. INTRINSIC SENSING INCREASED TO 8.1 MV AND PACING THRESHOLD MEASUREMENTS WERE 0.3 V AT 0.5 MS. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R E102| 0175