BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 4140518 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17567
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    February 2, 2013
    Report Date
    November 19, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0088-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DETAILED ANALYSIS IS ONGOING. 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). A REVISION PROCEDURE HAS BEEN SCHEDULED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. REVIEW OF THE DEVICE MEMORY INDICATED THAT A LOW VOLTAGE ALERT, CODE 1003, WAS RECORDED. 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 DEVICE PERFORMANCE WERE OBSERVED; BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE WERE VERIFIED. THE TITANIUM CASE WAS OPENED AND THE BATTERY WAS REMOVED, SO THAT AN EXTERNAL POWER SUPPLY COULD BE CONNECTED TO THE DEVICE FOR FURTHER ANALYSIS. A NORMAL CURRENT DRAIN WAS OBSERVED WITHIN THE CIRCUITRY. COLLECTIVELY, THE PATTERN OF IRREGULAR DAILY BATTERY VOLTAGE MEASUREMENTS IN CONJUNCTION WITH NORMAL POWER LEVELS AND DEVICE HYBRID CURRENT DRAW IS CONSISTENT WITH BEHAVIOR OF DEVICES WHERE A LATENT CURRENT LEAKAGE PATH HAS OCCURRED WITHIN THE BATTERY ITSELF, RESULTING IN A PARTIAL DEPLETION OF THE BATTERY.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WAS RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    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. DISK ANALYSIS SHOWED THE BATTERY APPEARS TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618142 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R F102