BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 4140060 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16815
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 5, 2014
    Report Date
    October 17, 2014
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DEVICE DATA WAS INSUFFICIENT TO OBTAIN BATTERY STATUS AND THE DEVICE HAD NO TELEMETRY. A MEMORY DOWNLOAD COULD NOT BE PERFORMED. THE DEVICE CASE WAS REMOVED AND THE DEPLETED CELL WAS REPLACED WITH A POWER SUPPLY WITHOUT BREAKING POWER THE DEVICE CURRENT WAS WITHIN NORMAL SPECIFICATIONS. CODE WAS DOWNLOADED INTO THE DEVICE, LOADS WERE ATTACHED TO THE OUTPUTS, AND THE DEVICE WAS PROGRAMMED TO NOMINAL SETTINGS. THE DEVICE CURRENT WAS WITHIN SPECIFICATIONS AND BOTH VENTRICLE AND ATRIAL PACING PULSES WERE PRESENT AND AS EXPECTED. IT WAS CONCLUDED THAT THE DEVICE HAD ACHIEVED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEVICE SYSTEM WAS PRESENTED WITH SYNCOPAL EPISODES. THE HEALTH CARE PROFESSIONAL (HCP) ENCOUNTERED DIFFICULTY INTERROGATING THE DEVICE, RECEIVING OUT OF RANGE TELEMETRY NOISE. TECHNICAL SERVICES WAS CONSULTED AND RECOMMENDED USING A NEW PROGRAMMER RECORDER MONITOR (PRM). A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS SOUGHT FROM THE LOCAL AREA SALES REPRESENTATIVE, HOWEVER, AT THIS TIME, ADDITIONAL INFORMATION WAS NOT AVAILABLE. A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619741 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Life Threatening 1298| 4086| 4034