BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1042094 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34553
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 18, 2008
    Report Date
    June 22, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES SUGGESTED PROGRAMMING A HIGHER THRESHOLD SAFETY MARGIN TO ENSURE NO LOSS OF CAPTURE. ALSO, THEY COULD DECREASE THE SENSITIVITY AND TURN ON THE AUTOMATIC CAPTURE FEATURE. NO FURTHER INFORMATION IS AVAILABLE. THIS EVENT WILL BE REOPENED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. THE DEVICE WAS SUBSEQUENTLY EXPLANTED FOR NORMAL BATTERY DEPLETION. 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. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. 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 DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) RECEIVED INFORMATION THAT THIS PACEMAKER HAD STORED ELECTROGRAMS OF FALSE VENTRICULAR TACHYCARDIA. THE ELECTROGRAMS WERE LIKELY DUE TO VENTRICULAR LOSS OF CAPTURE. THE EVENTS WERE ON TWO DAYS THAT WERE 6 MONTHS APART. THE PATIENT IS NOT SYMPTOMATIC. THE VENTRICULAR LEAD IS A NON-BSC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1190 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R