BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 7354966 · Received March 20, 2018

    Report

    Report Number
    2124215-2018-04566
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 12, 2018
    Report Date
    May 30, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    N970003/S096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT REMAINS IN-SERVICE. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER BATTERY AS SHOWING 1.5 YEARS REMAINING AT THE LAST TWO CHECKS, AND AT THE MOST RECENT VISIT WAS SHOWING 3.5 YEARS REMAINING. THERE WAS ALSO FLUCTUATING OUT OF RANGE LOW PACING IMPEDANCES LESS THAN 200 OHMS, AND OBSERVATIONS OF NOISE. THE PLAN WAS TO CONSIDER UNIPOLAR PACING AND DISK ANALYSIS AT NEXT FOLLOW-UP APPOINTMENT. THE DEVICE REMAINS IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT AT DEVICE CHECK TODAY THE LEAD HAD UNIPOLAR PACING IMPEDANCE CONSISTENT AT 310 OHMS (BIPOLAR 160-370 OHMS), AND THE BATTERY STATUS WAS SHOWING 3 YEARS. A DISK ANALYSIS WAS PERFORMED AND CONFIRMED THAT THE DEVICE HAS NO RESETS OR MEMORY ERRORS, AND THE POWER CONSUMPTION SHOWS THE DEVICE HAS APPROXIMATELY 3 YEARS REMAINING. PLAN WAS TO CONTINUE TO DO FOLLOW-UPS EVERY THREE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197476 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S602

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR