BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3905687 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11358
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 26, 2014
    Report Date
    May 29, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0088-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING AN OLDER SUBSET OF COGNIS/TELIGEN DEVICES THAT IS MORE SUSCEPTIBLE TO THIS ANOMALY. SPECIFICALLY, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING AN INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS PARTICULAR DEVICE WAS NOT INCLUDED IN THE AUGUST 29, 2013 ADVISORY POPULATION, BUT WAS ADDED TO THE EXPANDED POPULATION ON SEPTEMBER 17, 2014.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS DEVICE WAS EXPLANTED. 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. 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 NOT A PART OF THE IDENTIFIED POPULATION.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED THE FAULT CODE 1003 AND THE WARNING MESSAGE THAT THE VOLTAGE WAS TOO LOW FOR THE PROJECTED REMAINING CAPACITY. A MEMORY DOWNLOAD WAS PERFORMED AND SENT TO BOSTON SCIENTIFIC FOR FURTHER EVALUATION. A BOSTON SCIENTIFIC ENGINEER REVIEWED THE DATA AND CONFIRMED THAT A LOW VOLTAGE FAULT HAD BEEN DECLARED AS A RESULT OF AN ADDITIONAL CURRENT DRAIN ON THE DEVICE¿S BATTERY. AT THIS TIME DELIVERY IS CURRENTLY UNAFFECTED; HOWEVER, THE DEVICE IS MALFUNCTIONING AND SHOULD BE REPLACED. THE ICD HAS A SUFFICIENT RESERVE TO MAINTAIN NORMAL THERAPY FUNCTIONS FOR FOUR WEEKS. BEYOND THAT TIME, THERAPY COULD NOT BE GUARANTEED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384586 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 4087| 1861| 0157| E110| T167