BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3905770 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11762
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 3, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0026-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. REVIEW OF THE DEVICE MEMORY CONFIRMED THAT LOW VOLTAGE ALERTS (CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE IDENTIFIED A HOLE IN THE DF-1 (NEGATIVE) SEAL PLUG. ALL OF THE SETSCREWS OPERATED NORMALLY. LEAD SEAL WITNESS MARKS INDICATE THAT THE RA LEAD WAS NOT FULLY INSERTED INTO THE PORT BUT INSERTED FAR ENOUGH SO THAT THE SETSCREW ENGAGED THE LEAD TIP. THE WITNESS MARKS IN THE REMAINING PORTS INDICATE THAT ALL OTHER LEADS WERE FULLY INSERTED. INITIAL AUTOMATED TESTING VERIFIED BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE. USING HISTORICAL DAILY BATTERY VOLTAGE MEASUREMENT DATA, ENGINEERS DETERMINED THAT THIS DEVICE WAS DEMONSTRATING BEHAVIOR CONSISTENT WITH A HIGH CURRENT CONDITION ASSOCIATED WITH COMPROMISED LOW VOLTAGE (BYPASS) CAPACITORS CONNECTED TO THE DEVICE¿S BATTERY. LOW VOLTAGE CAPACITORS ARE USED IN THE DEVICE¿S HIGH-VOLTAGE CHARGING OPERATION IN ORDER TO FACILITATE FAST CHARGE TIMES. MALFUNCTION OF THESE CAPACITORS RESULTED IN A HIGH CURRENT DRAIN, WHICH WAS DEPLETING THIS DEVICE¿S BATTERY FASTER THAN NORMAL. ON AUGUST 29, 2013, BOSTON SCIENTIFIC DISTRIBUTED A LETTER TO PHYSICIANS CONCERNING THIS ISSUE. THIS LETTER INFORMED PHYSICIANS THAT, IN A SUBSET OF DEVICES, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS DEVICE IS A PART OF THE IDENTIFIED POPULATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY UNDERGOING LABORAOTRY TESTING TO DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS). THIS DEVICE DECLARED AN ALERT (CODE#1003). THE LOCAL REPRESENTATIVE WAS PLANNING TO SEND TS A DATA DISK FOR ANALYSIS BY IN-HOUSE ENGINEERING. IN-HOUSE ENGINEERING CONFIRMED THAT A LOW VOLTAGE ALERT WAS DECLARED IN (B)(6) 2014. THE VOLTAGE IS CURRENTLY 3.020 VOLTS AND THERAPY DELIVERY IS UNAFFECTED. THE DEVICE HARDWARE IS NOT DETECTING THE LOSS OF BATTERY ENERGY. BECAUSE OF THIS, THE BATTERY STATUS INDICATORS ARE NOT REFLECTING THE DEPLETION CONDITION AND ARE INACCURATE. USING HISTORICAL DAILY BATTERY VOLTAGE MEASUREMENT DATA, THE DAILY DEVICE POWER FLUCTUATIONS WERE ESTIMATED. TO DATE, THE CURRENT APPEARS STEADY; HOWEVER, THIS BEHAVIOR MAY CHANGE UNPREDICTABLY. AT THIS POINT, THE BATTERY DOES HAVE A SIGNIFICANT RESERVE CAPACITY. THE DATA INDICATES WITH A HIGH LIKELIHOOD THAT THERE IS SUFFICIENT RESERVE FOR THE DEVICE TO MAINTAIN NORMAL THERAPY FUNCTIONS FOR 28 DAYS' TIME. THE LOCAL REPRESENTATIVE WAS CONTACTED BY TS TO DISCUSS THE ISSUE AND RECOMMENDED THAT THE DEVICE SHOULD BE EXPLANTED. THE PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT INCIDENT. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383096 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R 4135| E110| 0185