BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3904889 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10027
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 9, 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 Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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 TWO LOW VOLTAGE ALERTS (CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. 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 (B)(4) 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).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DATA ANALYSIS SHOWED THE BATTERY APPEARS TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. AT THIS TIME, THE DEVICE REMAINS IMPLANTED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INDICATES THAT SURGICAL INTERVENTION WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384187 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R 7000| E102