BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2910536 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15451
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 14, 2012
    Report Date
    December 11, 2012
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN AND ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY TELEMETRY OPERATIONS WERE NORMAL. THE DEVICE WAS RETURNED WITH THE HEADER DETACHED. PROBES WERE USED TO PROBE THE HEADER WIRES IN ORDER TO TEST THE PACING AND SENSING, IT WAS CONFIRMED THAT THE DEVICE PACED AND SENSED NORMALLY. ALL IMPEDANCE MEASUREMENTS WERE STABLE AND NORMAL.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A NORMAL DEVICE REPLACEMENT PROCEDURE DUE TO NORMAL BATTERY DEPLETION. UPON EXTRACTING THE DEVICE, THE HEADER OF THE DEVICE SEPARATED FROM THE DEVICE. NO PACING WAS DELIVERED BUT THE PATIENT HAD AN INTRINSIC RHYTHM. A NEW DEVICE WAS IMPLANTED. THE EXPLANTED DEVICE WILL BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18401 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1295

    Patients

    Seq Age Sex Outcome Treatment
    1