BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1771358 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12469
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    March 15, 2010
    Report Date
    June 11, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH DEVICE EVALUATION WAS PERFORMED. MICROSCOPIC VISUAL INSPECTION NOTED NO IRREGULARITIES. ALL SEAL PLUGS INTACT AND ALL SETSCREWS MOVED FREELY. AN IS-1 LEAD WAS INSERTED INTO EACH LEAD BARREL AND EACH SET SCREW TIGHTENED ON THE LEAD PIN WITHOUT DIFFICULTIES. THE SEAL PLUGS WERE LIFTED AND MICROSCOPIC VISUAL INSPECTION NOTED NO IRREGULARITIES IN THE SETSCREWS OR SETSCREW THREADS. THE DEVICE PASSED ALL RETURN PRODUCT ELECTRICAL TESTING, AND THE REPORTED CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE PROCEDURE TO IMPLANT THIS PACING SYSTEM, BOTH LEADS WERE SUTURED DOWN AND VISUALIZED TO BE COMPLETELY INSERTED INTO THE DEVICE HEADER. HOWEVER, R-WAVES WERE UNABLE TO BE MEASURED AND VENTRICULAR IMPEDANCE WAS GREATER THAN 2500 OHMS. THE VENTRICULAR LEAD WAS REMOVED FROM THE DEVICE AND TESTING WITH THE PACING SYSTEM ANALYZER (PSA) PRODUCED NORMAL RESULTS. THE LEAD WAS THEN RE-INSERTED INTO THE HEADER, THE PROXIMAL SETSCREW WAS TIGHTED FIRST BUT THE LEAD CAME OUT WHEN TUGGED UPON. NEXT, THE LEAD WAS RE-INSERTED A SECOND TIME, BUT THE LEAD WAS STILL ABLE TO BE PULLED OUT OF THE HEADER AS THE REAR SETSCREW WOULD NOT ENGAGE AND TIGHTEN. A NEW PACEMAKER WAS UTILIZED AND IMPLANTED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S403

    Patients

    Seq Age Sex Outcome Treatment
    1