BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3052692 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03820
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 28, 2013
    Report Date
    April 29, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 LOW VOLTAGE BATTERY FAULTS (FAULT CODE 1003) HAD BEEN RECORDED. 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 CAPACITOR(S) 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. THE DEVICE WILL BE FORWARDED TO ARCHIVE.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE REMAINS IN SERVICE. A FINAL REPORT WILL BE SENT AFTER INFORMATION IS RECEIVED OF THE FOLLOW UP OF THE PATIENT PERFORMED BY THE PHYSICIAN. IF A REVISION PROCEDURE IS PERFORMED, AND THE PRODUCT IS RETURNED TO BOSTON SCIENTIFIC LABORATORY ANALYSIS WILL BE PERFORMED TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED BY BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND THE AGENT CONCLUDED-THE MEMORY DUMP DIAGNOSTIC DATA. A LOW_VOLTAGE FAULT WAS DECLARED ON (B)(6) 2013. THERE NO OTHER SUSPICIOUS FAULTS OR RESETS STORED WITHIN DEVICE MEMORY. THE VOLTAGE IS CURRENTLY 3.023 VOLTS, THERAPY DELIVERY IS UNAFFECTED. A LONGEVITY CALCULATION FOR THE DEVICE USING THE MEMORY DUMP DATA WAS PERFORMED AND ALL POWER LEVELS ARE IN LINE WITH NOMINAL VALUES. THE DEVICE HARDWARE IS NOT DETECTING THE LOSS OF BATTERY ENERGY AND BECAUSE OF THIS, THE BATTERY STATUS INDICATORS ARE NOT REFLECTING THE DEPLETION CONDITION AND ARE INACCURATE; THIS IS THE REASON FOR THE FAULT. THE AGENT CONCLUDED THAT THE DEVICE IS MALFUNCTIONING AND SHOULD BE REPLACED AND RETURNED TO ST. PAUL FOR DETAILED ANALYSIS. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN REVIEWED THE DEVICE INFORMATION AND THE ALERT AND FELT THE VOLTAGE WAS TOO LOW FOR THE EVALUATION OF THE REMAINING CAPACITY ON THE DEVICE. THE PHYSICIAN SUSPECTED PREMATURE BATTERY DEPLETION. THE PATIENT WILL BE CALLED TO SCHEDULE THE DEVICE REPLACEMENT.NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING REVIEW OF A PATIENT'S LATITUDE REPORTS, THE PHYSICIAN STATED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CAUSED AN ALERT TO BE DECLARED DUE TO THE BATTERY VOLTAGE BEING TOO LOW FOR THE PROJECTED REMAINING CAPACITY OF THE DEVICE. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT WAS CONTACTED AND ADVISED THAT THE PATIENT SHOULD BE BROUGHT INTO THE OFFICE FOR A DEVICE CHECK AS THIS ALERT IS DUE TO A DEVICE MALFUNCTION. THE AGENT RECOMMENDED THAT THE DEVICE BE REPLACED AS SOON AS POSSIBLE AND A SAVE ALL TO DISK AND MEMORY DUMP BE PERFORMED IN ORDER TO DETERMINE AND PROVIDED A TIMELINE FOR THE DEVICE CHANGE OUT. THE PATIENT WILL BE BROUGHT IN FOR A FOLLOW UP. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155506 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R