BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3904274 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-08251
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    December 11, 2013
    Report Date
    April 10, 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). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THIS DEVICE NOTED BODY FLUID CONTAMINATION IN BOTH LEAD BARRELS. DETAILED ANALYSIS FOUND ALL SETSCREWS MOVED FULLY AND FREELY IN BOTH DIRECTIONS. THE HEX SLOT ON THE PROXIMAL VENTRICULAR SETSCREW WAS SLIGHTLY ROUNDED OUT, INDICATING THE HEX WRENCH WAS NOT FULLY INSERTED INTO THE HEX SLOT BEFORE BEING TURNED. THIS RESULTED IN THE SETSCREW NOT TIGHTENING DOWN ON THE LEAD. THE PACING AND SENSING FUNCTIONS OF THE DEVICE WERE VERIFIED PER AUTOMATED TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, A SETSCREW ON THIS PACEMAKER BECAME STUCK AND COULD NOT BE TIGHTENED DOWN ONTO THE LEAD. A NEW DEVICE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384228 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 S603