BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3211240 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07951
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 24, 2013
    Report Date
    June 11, 2013
    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 Location
    AL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED FOR PREMATURE BATTERY DEPLETION. DURING THE PROCEDURE, THE PHYSICIAN NOTED THE HEADER WAS SEPARATED FROM THE CAN. THE DEVICE WAS RETURNED AND IS CURRENTLY UNDERGOING ANALYSIS. THIS REPORT WILL BE UPDATED WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    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 INCLUDED IN THE ADVISORY POPULATION.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. REVIEW OF THE DEVICE MEMORY CONFIRMED A LOW VOLTAGE BATTERY FAULT (FAULT CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED THE HEADER IS LIFTED FROM THE CASE. THERE ARE TOOL MARKS ON THE CASE AND ON THE HEADER, EVIDENCE SUGGESTS DAMAGE WAS INDUCED IN THE FIELD DURING THE EXPLANT PROCEDURE. INITIAL AUTOMATED TESTING VERIFIED BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE. AFTER THE TITANIUM CASE WAS OPENED, MICROSCOPIC VISUAL INSPECTION DID NOT REVEAL ANY IRREGULARITIES. THE BATTERY WAS THEN REMOVED, SO THAT AN EXTERNAL POWER SUPPLY COULD BE CONNECTED TO THE DEVICE FOR FURTHER ANALYSIS. A HIGHER THAN NORMAL CURRENT USAGE WAS OBSERVED. ELECTRICAL TESTING ISOLATED THE HIGH CURRENT CONDITION TO TWO COMPROMISED LOW VOLTAGE CAPACITORS THAT ARE CONNECTED TO THE DEVICE¿S BATTERY. THIS TYPE OF COMPONENT MALFUNCTION CAN RESULT IN A HIGH CURRENT DRAIN, WHICH OVER TIME CAN RESULT IN PREMATURE BATTERY DEPLETION, AS WAS OBSERVED IN THIS CASE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL PATIENT FOLLOW UP, 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. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 TWO WEEKS. BEYOND THAT TIME, THERAPY COULD NOT BE GUARANTEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310583 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 0180| E102