BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3243293 · Received July 23, 2013

    Report

    Report Number
    2124215-2013-09812
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 24, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0026-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. FAULT CODE 1003 WAS CONFIRMED TO HAVE BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. AFTER THE TITANIUM CASE WAS OPENED, MICROSCOPIC VISUAL INSPECTION DID NOT REVEAL ANY IRREGULARITIES. THE BATTERY VOLTAGE WAS LOWER THAN EXPECTED (2.983 VOLTS), BUT STILL SUPPORTED FULL DEVICE FUNCTION. 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 LOW-VOLTAGE (BYPASS) CAPACITORS CONNECTED TO THE DEVICE¿S BATTERY. LOW-VOLTAGE (BYPASS) 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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE DEVICE MEMORY SHOWED THAT ALL SHOCK LEAD IMPEDANCE MEASUREMENTS RECORDED FOR THE LAST YEAR WERE BETWEEN 73 OHMS AND 100 OHMS WITH THE MAJORITY OF THE MEASUREMENTS IN THE 80 OHM RANGE. EXTENSIVE SHOCK LEAD IMPEDANCE TESTING WAS PERFORMED AND ALL RECORDED MEASUREMENTS WERE WITHIN RANGE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS BEEPING AND DISPLAYED A FAULT CODE UPON INTERROGATION INDICATING THAT VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) EXPLAINED THAT SOMETHING WAS PREMATURELY DEPLETING THE BATTERY AND SUGGESTED THAT THE DEVICE SHOULD BE REPLACED IMMEDIATELY. TS STATED THAT THEY CAN DO A MEMORY DUMP TO FACILITATE THE SCHEDULING OF THE CHANGEOUT. THERE WERE NO PLANS OF REVISION AS OF THE MOMENT. THIS ICD REMAINS IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED THAT A DISK WAS SENT TO TS FOR ANALYSIS. THE DISK WAS CHECKED AND ENGINEERING ANALYSIS OF THE DATA DISK CONFIRMED A DEVICE ANOMALY. THE PHYSICIAN PLANNED A REVISION PROCEDURE TO EXPLANT THE DEVICE. THIS DEVICE WILL BE RETURNED TO BSC UPON EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS DONE IN WHICH THIS ICD WAS EXPLANTED AND REPLACED. THIS ICD WAS RETURNED FOR DETAILED ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BACK IN (B)(6) 2012, THE DEVICE'S HISTORY WAS SIGNIFICANT FOR A REPORT OF A LOW SHOCK IMPEDANCE MEASUREMENT (LESS THAN 20 OHMS). ADDITIONAL LABORATORY TESTING WAS PERFORMED TO ADDRESS THE CLINICAL OBSERVATION OF LOW SHOCK IMPEDANCE. SEE SUPPLEMENTAL REPORT#2124215-2012-03053.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342762 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR E110| 0181| 4470