BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3904168 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-08682
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    March 27, 2014
    Report Date
    May 12, 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). THE DEVICE IS CURRENTLY UNDERGOING DETAILED ANALYSIS TO DETERMINE ROOT CAUSE.

    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). 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. 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. ON AUGUST 29, 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). THE INVESTIGATION OF THIS EVENT IS ON-GOING AS A REQUEST HAS BEEN MADE TO THE LOCAL REPRESENTATIVE FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT INCIDENT. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS HEALTH CARE PROFESSIONAL (HCP) CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS). THE HCP INFORMED TS THAT THE PATIENT REPORTED BEEPING TONES FROM THE DEVICE. THE PATIENT WAS SEEN IN-CLINIC FOR A DEVICE CHECK AND UPON INTERROGATION, A VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY MESSAGE (LOW VOLTAGE ALERT) WAS DISPLAYED. ACCORDING TO A REPORT GENERATED FROM THE DEVICE, THE ALERT OCCURRED IN (B)(6) 2014. TS DISCUSSED THE ALERT AND RECOMMENDED THAT THE DEVICE SHOULD BE EXPLANTED. TS CONTACTED THE LOCAL REPRESENTATIVE WHO WAS INFORMED OF THE ALERT AND THE RECOMMENDATION FOR DEVICE EXPLANT. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED DATA FROM THE DEVICE ( MEMORY UPLOAD). THE DATA WAS REVIEWED AND A LOW VOLTAGE ALERT OCCURRING IN LATE-MARCH 2014 WAS CONFIRMED. THE VOLTAGE IS CURRENTLY 3.022 VOLTS, 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. THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE REMAINS IN-SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382974 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR E110| 0175| 4470