BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3904822 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09947
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 30, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 FOLLOWING AN UNRELATED PROCEDURE, THE DEVICE WAS NOTED TO BE AP-VS AT A RATE OF 150 BEATS PER MINUTE (BPM). THE DEVICE WAS PROGRAMMED TO A MAX TRACKING RATE OF 130 BPM AND A MAX SENSING RATE OF 150 BPM. IT WAS NOTED THAT THE RATE TRENDED AT A RATE OF 150, HOWEVER, WENT DOWN ON ITS OWN. THE PATIENT'S INTRINSIC RATE WAS 65 BPM. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED HOSPITAL MONITORING EQUIPMENT INTERACTION WITH THE MINUTE VENTILATION (MV) FEATURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383505 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 4470| S603| 4076