BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3904514 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09431
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    D970003/S106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS WERE OBSERVED THAT RESULTED IN ACTIVATION OF THE LSS FEATURE. THE LEAD REMAINS PROGRAMMED IN BIPOLAR CONFIGURATION. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER AND RIGHT ATRIAL (RA) LEAD EXHIBITED AN UNSPECIFIED OUT OF RANGE PACING IMPEDANCE MEASUREMENT RESULTING IN ACTIVATION OF THE LEAD SAFETY SWITCH (LSS) FEATURE. ADDITIONALLY, SEVERAL EPISODES OF NOISE WERE RECORDED RESULTING IN INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) MODE SWITCHES. NOISE WAS UNABLE TO BE REPRODUCED IN CLINIC WITH PATIENT ISOMETRICS, ALL LEAD MEASUREMENTS WERE NOTED TO BE STABLE AND PACING IMPEDANCE MEASUREMENTS WERE NOTED TO BE 470 OHMS IN BIPOLAR AND UNIPOLAR CONFIGURATIONS. HOWEVER, WHEN THE LEAD WAS PROGRAMMED TO UNIPOLAR CONFIGURATION, THE LSS FEATURE RE-ACTIVATED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POST RADIATION RECOMMENDATIONS. THE LEAD WAS LEFT PROGRAMMED IN BIPOLAR CONFIGURATION. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384597 ALTRUA LWP GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 1270| 4271| S606| 4034