BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 4140474 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17375
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 15, 2014
    Report Date
    December 9, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0087-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    (B)(4). THE DEVICE REMAINS IN SERVICE AT THIS TIME. THIS REPORT WILL UPDATED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED. THE FIELD REPRESENTATIVE WAS CONTACTED AND DOES NOT HAVE POSSESSION OF THE DEVICE AS IT WAS RETAINED BY THE HOSPITAL. SHOULD THE DEVICE GET RETURNED AT A LATER DATE, IT WOULD BE ANALYZED AND THIS REPORT WOULD BE UPDATED.

    Description of Event or Problem · 1

    AS PART OF AN ANALYSIS TO REVIEW THE SAFETY ARCHITECTURE LOW VOLTAGE ALERT (CODE 1003), BATTERY VOLTAGE DATA WAS PULLED FROM THE REMOTE PATIENT MONITORING SYSTEM. DURING OUR ANALYSIS, THE DEVICE WAS IDENTIFIED AS DEMONSTRATING EVIDENCE OF PREMATURE BATTERY DEPLETION THAT COULD POTENTIALLY LEAD TO COMPROMISED THERAPY IF NOT ADDRESSED IN A TIMELY MANNER. BOSTON SCIENTIFIC TECHNICAL SERVICES PROACTIVELY REACHED OUT TO THE FIELD REPRESENTATIVE TO NOTIFY THEM OF THIS FINDING AND RECOMMEND DEVICE REPLACEMENT. AT THIS TIME, THE DEVICE REMAINS IMPLANTED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE DEVICE WAS SUBSEQUENTLY EXPLANTED IN (B)(6) 2014. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT THE PATIENT HAD BEEN SCHEDULED FOR A DEVICE REPLACEMENT ON (B)(6) WHICH WAS ONE DAY BEFORE THE ORIGINAL REPLACEMENT DATE RECOMMENDED. SINCE THEN, THE PATIENT HAS BECOME QUITE ILL, THEREFORE WILL NOT UNDERGO A REPLACEMENT AT THIS TIME. THE FIELD REPRESENTATIVE REQUESTED AN UPDATED ANALYSIS OF DATA PULLED FROM THE REMOTE PATIENT MONITORING SYSTEM. ENGINEERING CONFIRMED THAT AS OF THE LAST REMOTE MONITORING UPLOAD ON (B)(6), THE NOMINAL RATE OF BATTERY DEPLETION HAS VARIED LARGE. USING A CONSERVATIVE ESTIMATE, ENGINEERING DISCUSSED THAT TACHY THERAPY MAY BE IMPACTED AFTER 70 DAYS OR (B)(6) 2014 AND BRADY THERAPY MAY SHUT OFF IN APPROXIMATELY 100 DAYS OR (B)(6) 2015. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618189 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R 0158| 4470| 1861| 4549| N119