BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2051784 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03696
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THIS DEVICE SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS INVESTIGATION WILL BE REOPENED AND UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION CONFIRMED THAT THE DEVICE WAS RETURNED WITH A DETACHED HEADER, AND THE ATRIAL SETSCREW WAS STUCK IN THE FULLY OPEN POSITION. ALL SEAL PLUGS EXCPET THE VENTRICULAR TIP, WERE MISSING. BOTH ATRIUM CAPTURE WASHERS ARE BENT, AND SETSCREWS STUCK IN THE UP POSITION, THIS IS LIKELY DUE TO SETSCREWS BACKED OUT TO FAR. THERE WAS DAMAGE TO CAPTURE WASHERS WHICH WAS DUE TO THE USE OF AN INCORRECT OR BROKEN WRENCH. THE DEVICE HEADER WAS CHECKED PER "OSCOR IS-1 LEAD GAUGE PIN", AND PASSED. THE DEVICE WAS CHECKED WITH IS-1 LEAD AND FIT WAS NORMAL. THE DEVICE TIP & RING SETBLOCKS WERE CHECKED WITH PIN GAGES THAT EXCEEDED IS-1 SPECS. THE DEVICE VENTRICLE SETSCREWS MOVED FREELY WITH NO BINDING. THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIES THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS OF THE DEVICE COMMENSURATE WITH BATTERY VOLTAGE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RECENT DEVICE UPGRADE PROCEDURE, IT WAS NOTED THAT THE ATRIAL LEAD WAS STUCK IN THE PIN PORT AND THE SET SCREW WAS FROZEN. THE DEVICE HEADER HAD TO BE REMOVED IN ORDER TO DISENGAGE THE ATRIAL LEAD. THE ATRIAL LEAD WAS RE USED IN THE NEWLY IMPLANTED REPLACEMENT DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)