BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 4150839 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-16843
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 20, 2014
    Report Date
    October 30, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED AND THE RA LEAD WAS SURGICALLY ABANDONED. THE DEVICE REMAINS ACTIVELY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PACEMAKER WITH RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCE OF 2,380 OHMS. PREVIOUS IMPEDANCE CHECK WAS AT 800 OHM RANGE, NO NOISE WAS NOTED AND NO REPORT OF LEAD SAFETY SWITCH BEING TRIPPED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED NORMAL IMPEDANCE RANGE. ADDITIONAL INFORMATION INDICATED THAT THE CAUSE WAS UNDETERMINED AND THE PATIENT WILL LIKELY BE SCHEDULED FOR A REVISION PROCEDURE, HOWEVER NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE SYSTEM REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632745 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 4457| S603| 4480