BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 3921846 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-10548
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 14, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THE DEVICE AND COMPETITOR RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND WAS REPLACED WITH NO ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER EXHIBITED NOISE BEING OVERSENSED. THERE WERE VENTRICULAR TACHYCARDIA STORED IN ELECTROGRAM (EGM). THE PATIENT HAD ATRIOVENTRICULAR NODE ABLATION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THE CAUSE OF DOUBLE COUNTING WAS DUE TO NOISE. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS ADMITTED FOR LEAD REVISION AND DEVICE REPLACEMENT. HOWEVER, IT WAS DETERMINED THAT THE VEIN WAS OCCLUDED SO AT THAT POINT FURTHER SURGICAL INTERVENTION WAS ABANDONED. UPON FURTHER ISOMETRIC EVALUATION THE ASYSTOLE WAS REPRODUCED GREATER THAN 2 SECONDS AND IT WAS IDENTIFIED THAT THERE WAS EITHER AN INSULATION BREACH OR CONDUCTOR ISSUE ON COMPETITOR'S RV LEAD. PROGRAMMING CHANGES WERE DONE AND IMPEDANCE RETURNED TO 550 OHMS. THE PATIENT WILL THEN BE MONITORED AND WAS SCHEDULED FOR FULL SYSTEM EXTRACTION. THE SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400155 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R 1297| 5076