BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVENE

    MDR report key: 2308064 · Received October 26, 2011

    Report

    Report Number
    2124215-2011-17972
    Event Type
    Injury
    Date Received
    October 26, 2011
    Date of Event
    August 3, 2011
    Report Date
    September 22, 2011
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE LEAD REMAINS IMPLANTED. 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 HAD DISPLAYED OUT OF RANGE SHOCKLING IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERVENE IMPLANTABLE LEAD NVY GUIDANT ANGLETON/ST. PAUL 497-23

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Life Threatening| R E102| (B)(4)| 1860| (B)(4)