BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1043427 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33227
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 6, 2008
    Report Date
    November 15, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z0187-94/6
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. ANALYSIS WAS UNABLE TO CONFIRM THE ALLEGATION MADE AGAINST THIS DEVICE IN THE FIELD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, THIS PACEMAKER WAS UNABLE TO BE INTERROGATED AS TELEMETRY COULD NOT BE ESTABLISHED WITH IT. AT THE TIME OF THE EVENT, NO FURTHER ACTION WAS TAKEN AND THE PACEMAKER CONTINUED TO REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. APPROXIMATELY EIGHT YEARS LATER THE PACEMAKER WAS ELECTIVELY EXPLANTED AND RETURNED WITHOUT ANY FURTHER ALLEGATION BEING MADE AGAINST IT IN RELATION TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other