BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERVENE

    MDR report key: 3582565 · Received January 17, 2014

    Report

    Report Number
    2124215-2013-21319
    Event Type
    Malfunction
    Date Received
    January 17, 2014
    Date of Event
    October 16, 2013
    Report Date
    October 17, 2013
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 VIA THE PATIENT REMOTE MONITORING SYSTEM THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE (SLI) MEASUREMENT OF GREATER THAN 125 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE RED ALERT STATUS. ADDITIONAL INFORMATION OBTAINED FROM THE FIELD REPRESENTATIVE INDICATED THAT THE CAUSE OF THE OOR SLI WAS NOT DETERMINED. THE PATIENT WAS FOR POSSIBLE DEFIBRILLATION THRESHOLD (DFT) TEST IN THE FUTURE. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44224 INTERVENE IMPLANTABLE LEAD NVY GUIDANT ANGLETON/ST. PAUL 497-23

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR E143| 1861| 101-10| 497-23| MISMATCH| T127