BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3905651 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11531
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 CONCLUDED THAT THE ERROR CODES IN DEVICE MEMORY AS WELL AS THE SAFETY MODE OPERATION WERE INDUCED AS A RESULT OF CONTINUOUS APPLICATION OF A MAGNET TO THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER EXHIBITED THREE UNSPECIFIED ERROR CODES AND WAS OBSERVED TO BE IN SAFETY MODE UPON INTERROGATION WITH A PROGRAMMER. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED DEVICE REPLACEMENT. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383999 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 4285| 1297| 4269| 294-09E| K173