BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2151749 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-09163
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 2, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PACEMAKER WAS EXPLANTED AND REPLACED, BUT WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING THE FOLLOW-UP PROCEDURE, IT WAS OBSERVED THIS PACEMAKER EXHIBITED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. A REPLACEMENT PROCEDURE WILL BE SCHEDULED FOR THE NEAR FUTURE. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THE PHYSICIAN NOTICED THE ASSOCIATED RV LEAD WAS FRACTURED, SO ELECTED TO REPLACE THE ENTIRE SYSTEM. THE REPLACEMENT SYSTEM WERE COMPETITOR PRODUCTS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1292

    Patients

    Seq Age Sex Outcome Treatment
    1