BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 4150861 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-17495
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 RIGHT VENTRICULAR PACING, AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. LABORATORY 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 RECEIVED INFORMATION THAT THIS DEVICE AND THE COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSED NOISE THAT RESULTED TO PACING INHIBITION WITH GREATER THAN TWO SECONDS ASYSTOLE. ADDITIONAL INFORMATION WAS RECEIVED AND INDICATED THAT THE CAUSE OF THE OBSERVATIONS WAS NOT DETERMINED AND THE CONNECTION TO THE DEVICE HEADER SEEMED FINE UPON REMOVAL OF THE DEVICE. THE DEVICE WAS EXPLANTED AND THE RV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633573 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R PY52PSBV| K173| MISMATCH| 1297| 4137