BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2170307 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10956
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 8, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS PERFORMED AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. VISUAL ANALYSIS CONFIRMED THE OBSERVATION OF A LOOSE HEADER. THE MEDICAL ADHESIVE WAS STILL ATTACHED TO THE HEADER AND WAS DETERMINED TO BE ADEQUATE. AN X RAY REVEALED NO BREAKS IN THE FEED THRU WIRES DUE TO THE HEADER SEPARATION. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILBLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PULSE GENERATOR WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. DURING THE EXPLANT PROCEDURE, THE HEADER OF THE DEVICE WAS NOTED TO BE LOOSE. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 4004| 1297| MISMATCH| 7074| 4469| S602