BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3904798 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10419
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 16, 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 Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 THAT A LOW VOLTAGE ALERT (CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. THE DEVICE WAS THEN SUBJECTED TO AUTOMATED TESTING TO VERIFY PROPER OPERATION. THE DEVICE WOULD NOT PASS DUE TO A LOW BATTERY. 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. 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.

    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). THE DEVICE IS CURRENTLY UNDERGOING LABORATORY TESTING TO DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS). ACCORDING TO THE CLINIC NURSE, THE PATIENT HAD BEEN ADMITTED INTO THE HOSPITAL DUE TO CHEST PAIN (NON-DEVICE RELATED ISSUE). THE DEVICE WAS INTERROGATED AND A CODE#1003 WAS DISPLAYED. DATA FROM DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC FOR ANALYSIS. IT WAS CONFIRMED THROUGH DATA ANALYSIS THAT A LOW VOLTAGE FAULT HAD BEEN DECLARED IN (B)(6) 2014. THE VOLTAGE IS CURRENTLY 3.019 VOLTS AND THERAPY DELIVERY IS UNAFFECTED. THE DEVICE HARDWARE IS NOT DETECTING THE LOSS OF BATTERY ENERGY. BECAUSE OF THIS, THE BATTERY STATUS INDICATORS ARE NOT REFLECTING THE DEPLETION CONDITION AND ARE INACCURATE. USING HISTORICAL DAILY BATTERY VOLTAGE MEASUREMENT DATA, THE DAILY DEVICE POWER FLUCTUATIONS WERE ESTIMATED. TO DATE, THE CURRENT APPEARS STEADY; HOWEVER, THIS BEHAVIOR MAY CHANGE UNPREDICTABLY. AT THIS POINT, THE BATTERY DOES HAVE A SIGNIFICANT RESERVE CAPACITY. THE DATA INDICATES THAT THERE IS SUFFICIENT RESERVE FOR THE DEVICE TO MAINTAIN NORMAL THERAPY FUNCTIONS FOR 28 DAYS' TIME. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT INCIDENT.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382295 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R 0185| E102