BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1860478 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15102
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 26, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED THAT BOTH SEAL PLUGS APPEARED NORMAL AND UNDAMAGED. INSPECTION OF THE SET SCREWS NOTED THAT THE DISTAL SET SCREW WAS STUCK IN THE UP POSITION. AN X-RAY PERFORMED ON THE DEVICE CONFIRMED THAT THE DISTAL SET SCREW WAS CROSS THREADED AND TILTED IN THE CONNECTOR BLOCK. HIGH POWERED MICROSCOPIC VISUAL INSPECTION OF THE DISTAL SET SCREW NOTED DAMAGE TO THE THREADS ON THE SCREW, INDICATING THAT IT HAD BEEN TILTED WHEN AN ATTEMPT WAS MADE IN THE FILED TO TIGHTEN IT TO THE LEAD. THE DEVICE WAS THEN SUBJECTED TO AND PASSED ALL AUTOMATED ELECTRICAL TESTING WHICH CONFIRMED PROPER OPERATION OF THE PACING AND SENSING FUNCTIONS OF THE DEVICE. ALL DIMENSIONS OF THE LEAD BARREL OF THE DEVICE WERE FOUND TO BE WITHIN SPECIFICATIONS. A BOSTON SCIENTIFIC IS-1 LEAD WAS TESTED ON THE DEVICE. THE LEAD COULD BE FULLY INSERTED INTO THE LEAD BARREL NUMEROUS TIMES. NO ABNORMAL DIFFICULTIES WERE NOTED DURING LEAD INSERTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THE INCLUDED WITH THIS PACEMAKER WAS USED TO FIX THE SETSCREW. HOWEVER, THE LEAD WAS NOT FIXED IN THE HEADER ON THE DISTAL (LEAD PIN) CONNECTION. THE LEAD WAS PULLED BACK AND ATTEMPTED AGAIN WITHOUT SUCCESS. THE LEAD WAS STILL LOOSE IN THE HEADER AFTER FIXING THE SETSCREW. THE DEVICE WAS REMOVED, SUCCESSFULLY REPLACED, AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S601

    Patients

    Seq Age Sex Outcome Treatment
    1 Other