BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 4884739 · Received July 1, 2015

    Report

    Report Number
    2124215-2015-07341
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    May 27, 2015
    Report Date
    August 17, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS BY THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    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. REVIEW OF THE DEVICE MEMORY VERIFIED THAT A LOW VOLTAGE ALERT, CODE 1011, WAS RECORDED. THE DEVICE WAS EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING, AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY DURING MOST TESTING; HOWEVER, THE MEASUREMENTS DURING THE BATTERY USAGE TEST WERE OUT OF RANGE; INDICATING A HIGH CURRENT. THE TITANIUM CASE WAS OPENED AND THE BATTERY WAS REMOVED SO THAT AN EXTERNAL POWER SUPPLY COULD BE CONNECTED TO THE DEVICE FOR FURTHER ANALYSIS. ELECTRICAL TESTING ISOLATED THE HIGH CURRENT CONDITION TO A CAPACITOR IN THE DEVICE'S INTERNAL CIRCUITRY. THE HIGH CURRENT CONDITION RESULTED IN THE BATTERY VOLTAGE INDICATED BY THE DEVICE TO BE HIGHER THAN THE EXPECTED PARAMETERS. THE CAPACITOR WAS REMOVED AND SUBSTITUTED FOR ANOTHER CAPACITOR, WHICH RESTORED THE DEVICE BACK TO NORMAL MEASUREMENTS. LABORATORY ANALYSIS CONCLUDED THAT THE CODE 1011 WAS A RESULT OF A CAPACITOR EXPERIENCING A HIGH CURRENT DRAIN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DISPLAYED A CODE 1011 INDICATING THAT THE BATTERY VOLTAGE WAS HIGHER THAN EXPECTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND A TS CONSULTANT DISCUSSED THAT THE DEVICE SHOULD BE REPLACED AS THIS ISSUE COULD EFFECT THERAPY AVAILABILITY. THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427451 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 4136| K173| L321