BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3904816 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10805
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 7, 2014
    Report Date
    May 30, 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
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RETURN, THE DEVICE WILL UNDERGO DETAILED ANALYSIS TO DETERMINE ROOT CAUSDE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 THREE LOW VOLTAGE ALERTS (CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. THE DEVICE WAS RETURNED WITH A BATTERY STATUS INDICATOR OF END-OF-LIFE (EOL) ASSOCIATED WITH A MONITORING VOLTAGE OF 2.385 VOLTS. THE DEVICE WAS PUT THROUGH A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIES THE PERFORMANCE OF DEFIBRILLATION, PACING, SENSING AND RECORDING FUNCTIONS OF THE DEVICE. THE DEVICE FAILED THE RV PACE SHOCK PORTION OF THE TEST DUE TO LOW BATTERY VOLTAGE. 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.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT CONTACTED BOSTON SCIENTIFIC'S PATIENT SERVICES TO REPORT THAT THIS DEVICE IS GENERATING BEEPING TONES. SUBSEQUENTLY, THE LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO REPORT THAT THIS DEVICE DECLARED ALERT#1003 (LOW VOLTAGE ALERT) AND ALERT (B)(4)(CHARGE TIME EXCEEDS 45 SECONDS). TS DISCUSSED THE ISSUE AND RECOMMENDED IMMEDICATE REPLACEMENT AS THERAPY MAY BE COMPROMISED. THE PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383504 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R E110| 0154| 1861| 4470