BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780934 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13428
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 2, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED NO CAPTURE AT MAXIMUM OUTPUTS. R-WAVE MEASUREMENTS HAD DECREASED AND PACING IMPEDANCE MEASUREMENTS DECREASED FROM 1,400 OHMS AT IMPLANT TO 300 OHMS. UPON FLUOROSCOPY, THE RV LEAD APPEARED TO BE DISLODGED. THE PATIENT WITH THIS LEAD CONTINUED TO EXPERIENCE A NORMAL SINUS RHYTHM, WITH NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE WAS REPROGRAMMED TO VVI 40. A 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 NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R N140| 4548| 4135| 0295