BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3905337 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11011
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 10, 2014
    Report Date
    June 13, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE HEADER FOUND THAT THE RIGHT VENTRICULAR (RV) RING SETSCREW WAS VISIBLE UP PAST THE SEAL PLUG. THE RV RING SETSCREW WAS REMOVED AND THERE WAS A LARGE HOLE NOTED TO THE SEAL PLUG, WITH SECTIONS THAT WERE COMPLETELY MISSING. IN ADDITION, THE SEAL PLUG OF THE RV TIP ALSO HAD A LARGE HOLE AND WHITE FOREIGN MATERIAL WAS PRESENT IN THE RV PORT. FURTHER INSPECTION OF THE RV PORT CONFIRMED THAT THE FOREIGN MATERIAL WERE PIECES OF THE DAMAGED SEAL RINGS WITHIN THE THREADS AND INSIDE THE CONNECTOR BLOCK. MICROSCOPIC INSPECTION OF THE SETSCREWS FOUND NO EVIDENCE OF CROSS-THREADING. THESE PIECES IN THE RV PORT WERE REMOVED AND ADDITIONAL TESTING WAS PERFORMED. MULTIPLE LEADS WERE INSERTED INTO EACH DEVICE PORT WITHOUT ANY ISSUES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS DETERMINED THAT THE ISSUES OBSERVED DURING THE IMPLANT PROCEDURE WITH THE SETSCREWS NOT BEING ABLE TO BE TIGHTENED ON THE LEAD WERE MOST LIKELY DUE TO THE DAMAGED SEAL PLUGS SECTIONS THAT THERE WERE FOUND WITHIN THE RV PORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS PACEMAKER, THE LEAD WAS UNABLE TO BE CONNECTED TO THE DEVICE DUE TO AN ISSUE WITH THE SETSCREW. THIS PACEMAKER WAS NOT USED AND REPLACED WITH A COMPETITOR'S PRODUCT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ---

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382232 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S206

    Patients

    Seq Age Sex Outcome Treatment
    1 MISMATCH| S206