BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3070421 · Received April 22, 2013

    Report

    Report Number
    2124215-2013-06509
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 29, 2013
    Report Date
    June 30, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER UNDERWENT AN UNRELATED SURGICAL PROCEDURE. DURING THE PROCEDURE, A MAGNET WAS PLACED OVER THE DEVICE AND PACING WAS OBSERVED TO BE 100PPM. APPROXIMATELY THIRTY MINUTES LATER, WHILE UNIPOLAR CAUTERY WAS BEING USED, THE PACED RATE DECREASED UNTIL NO PACING OUTPUT WAS OBSERVED. THE DEVICE SUBSEQUENTLY BEGAN PACING AGAIN ON ITS OWN THE PHYSICIAN FINISHED THE PROCEDURE WITH BIPOLAR BOVIE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED A POTENTIAL DEVICE RESET AND RECOMMENDED INTERROGATION OF THE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS EXPLANTED AND REPLACED FOR REPORTED NORMAL BATTERY DEPLETION TWO YEARS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172344 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 4457| 4470| 1290