BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1851958 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14460
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 12, 2010
    Report Date
    June 30, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A BSC CRM TECHNICAL SERVICES CONSULTANT DISCUSSED HOW THE MAGNET APPLICATION AFFECTS THE PACEMAKER AND THAT 100PPM IS THE EXPECTED MAGNET RATE. THE CALLER FELT THAT THE RATE WAS TOO FAST AND REQUESTED ASSISTANCE TO REPROGRAM A LOWER RATE. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS ELECTIVELY EXPLANTED EIGHT MONTHS AFTER THE INITIAL CLINICAL OBSERVATIONS. UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. NORMAL PACING AND SENSING WAS NOTED WITH NO PAUSES IN PACING OR OVERSENSING OBSERVED. THE DEVICE WAS THEN PUT THROUGH AND PASSED THE RETURNED PRODUCTS TEST (RPT). THIS INVOLVES A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIES THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS OF THE DEVICE COMMENSURATE WITH BATTERY VOLTAGE. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THIS PATIENT HAS UNDERGONE AN UNSPECIFIED SURGERY AT WHICH TIME, THIS PACEMAKER OVERSENSED ELECTROCAUTERY WHICH RESULTED IN PAUSES IN PACING. A MAGNET WAS PLACED ON THE DEVICE AND PACING AT 100PPM ENSUED.

    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 77 YR 4469| 4087| 1290