BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIPASS

    MDR report key: 2041617 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01198
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 15, 2011
    Report Date
    January 15, 2011
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER DEPENDANT PATIENT IS EXHIBITING NOISE WHICH IS CAUSING PACING INHIBITION. A BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) NOTED THAT THEY CANNOT ALWAYS SEE THE ATRIAL SENSE (AS) MARKERS AS THEY ARE LINING UP WITH THE VENTRICULAR PACE MARKERS. TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED INCREASING THE SENSITIVITY SETTINGS. THE SENSING CONFIGURATION CANNOT BE CHANGED AS THIS LEAD IS A UNIPOLAR LEAD. IN ORDER TO BEST PROVIDE A/V SYNCHRONY IS SUGGESTED LOWERING THE LOWER RATE LIMIT (LRL) BY 10 BPM, AND THAT RESOLVED THE MISSING AS MARKERS ISSUE. ANOTHER SUGGESTION WAS OFFERED TO CHANGE THE CURRENT DEVICE PROGRAMMING TO DDD BUT THAT COULD HAVE AN IMPACT ON LONGEVITY LONG TERM. ULTIMATELY THE SR LOWERED THE LRL TO 65 BPM AND THAT WAS SUFFICIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIPASS IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 426-33

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other| R (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)