BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3955854 · Received July 24, 2014

    Report

    Report Number
    2124215-2014-14457
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 29, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DEVICE DATA WAS INSUFFICIENT TO OBTAIN BATTERY STATUS. NO TELEMETRY WAS AVAILABLE AND MEMORY DOWNLOAD COULD NOT BE PERFORMED. EXTERNAL VISUAL INSPECTION NO IRREGULARITIES. THE PULSE GENERATOR CASE WAS REMOVED AND INTERNAL VISUAL INSPECTION NOTED NO IRREGULARITIES. FURTHER TESTING CONFIRMED THAT THE CAUSE OF THE NO TELEMETRY CONDITION WAS A DEPLETED CELL. THE CAUSE OF THE DEPLETED CELL WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, INITIAL ANALYSIS DETERMINED THAT THE DEVICE DATA WAS INSUFFICIENT TO OBTAIN BATTERY STATUS. ADDITIONALLY, THE DEVICE HAD NO TELEMETRY AND A MEMORY DOWNLOAD WAS UNABLE TO BE PERFORMED. ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT IN PREPARATION FOR A ROUTINE IMPLANT PROCEDURE, THIS BOXED DEVICE WAS EXHIBITING OUT OF RANGE TELEMETRY, TELEMETRY NOISE, DEVICE NOISE AND DEVICE NOT IDENTIFIED ERROR MESSAGES. A SECOND DEVICE OF THE SAME MODEL WAS SUCCESSFULLY INTERROGATED WITH THE SAME PROGRAMMER RECORDER MONITOR (PRM) AND WAND. TECHNICAL SERVICES WAS CONSULTED AND ADVISED NOT IMPLANTING THIS DEVICE. THE DEVICE WAS NOT IMPLANTED AND WAS RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433762 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1