BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3921659 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-11430
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    D970003/S106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LEAD SAFETY SWITCH (LSS) WAS TRIGGERED ON THIS IMPLANTABLE PACEMAKER AND RIGHT ATRIAL (RA) LEAD. IMPEDANCE TREND RANGE FROM 300 TO 710 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THE LEAD WILL SWITCH FOR ONE OUT OF RANGE IMPEDANCE, EITHER LESS THAN 100 OHMS OR GREATER THAN 2,500 OHMS. FURTHERMORE, THRESHOLD WAS GOOD AND A RESET WAS PERFORMED. AN OVERSENSED NOISE WAS ALSO OBSERVED WHILE THE DEVICE WAS IN UNIPOLAR. THE HEALTH CARE PROFESSIONAL (HCP) PLANNED TO SEE THE PATIENT BACK IN CLINIC EARLIER THAN USUAL FOR FURTHER ASSESSMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE WERE UNSUCCESSFUL. 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
    399871 ALTRUA LWP GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 4473| S606| 4137