BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2911853 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16331
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    August 8, 2012
    Report Date
    December 7, 2012
    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 A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. VISUAL INSPECTION NOTED THE HEADER AS LOOSE. THE HEADER WAS NOT ADHERED TO THE CASING ON THE SERIAL NUMBER SIDE. X-RAY NOTED NO FRACTURE OF THE FEED THRU WIRES. BASED ON AVAILABLE DATA, THE DEVICE HAD A NOMINAL LONGEVITY OF 10 YEARS AND WAS IMPLANTED FOR 8.0 YEARS AND ACHIEVED 80% OF NOMINAL LONGEVITY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP APPOINTMENT, THE RIGHT ATRIAL IMPEDANCE TEST WAS PERFORMED AND RESULTED IN AN ERROR MESSAGE OF NOT IDENTIFIED. THEREFORE, THE EXACT IMPEDANCE MEASUREMENT COULD NOT BE DISPLAYED. HOWEVER, THE WHOLE HISTORY OF LEAD IMPEDANCE MEASUREMENTS WAS PRESENT AND CORRECTLY RECORDED. THIS DEVICE WAS SUBSEQUENTLY EXPLANTED FOR NORMAL BATTERY DEPLETION. WHEN THE NEW DEVICE WAS IMPLANTED, ALL IMPEDANCE MEASUREMENTS WERE OBTAINED AND WERE APPROPRIATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16327 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1292

    Patients

    Seq Age Sex Outcome Treatment
    1