BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 4140487 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17214
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 6, 2014
    Report Date
    October 9, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    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). THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. THE BATTERY VOLTAGE WAS LOWER THAN EXPECTED, BUT STILL SUPPORTED FULL DEVICE FUNCTION. A SERIES OF AUTOMATED ELECTRICAL/FUNCTIONAL TESTS WERE CONDUCTED AND NO ISSUES WITH THE DEVICE¿S ABILITY TO DELIVER THERAPY WERE OBSERVED; BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE WERE VERIFIED. USING HISTORICAL DAILY BATTERY VOLTAGE MEASUREMENT DATA, ENGINEERS DETERMINED THAT THIS DEVICE WAS DEMONSTRATING BEHAVIOR CONSISTENT WITH A HIGH CURRENT CONDITION ASSOCIATED WITH A COMPROMISED LOW VOLTAGE CAPACITOR 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. 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 INCLUDED IN THE ADVISORY POPULATION

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE NON-BSC RIGHT VENTRICULAR (RV) LEAD DISPLAYED INCREASED, BUT UNSPECIFIED PACING IMPEDANCE AND THRESHOLD MEASUREMENTS. AN INVASIVE PROCEDURE WAS PERFORMED AND THE RV LEAD WAS REVISED. APPROXIMATELY SIX WEEKS LATER, UPON ROUTINE DEVICE INTERROGATION, A FAULT CODE INDICATING VOLTAGE TOO LOW FOR PROJECTED REMAINING LONGEVITY WAS OBSERVED. TECHNICAL SERVICES WAS CONSULTED AND DISCUSSED DEVICE REPLACEMENT. A REVISION PROCEDURE WAS TO BE SCHEDULED. ADDITIONAL INFORMATION WAS SOUGHT FROM THE LOCAL AREA SALES REPRESENTATIVE, HOWEVER, AT THIS TIME ADDITIONAL INFORMATION WAS NOT AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618822 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R 6947| 5076| E110| 1861