BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3904870 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09639
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 18, 2014
    Report Date
    September 17, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0087-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REQUESTED OF THE FIELD REPRESENTATIVE. THE ALERT 1007 WAS SUSPECTED TO BE A RESULT OF THE LOW VOLTAGE CAPACITOR ISSUE. THE DEVICE WAS EXPLANTED AND REPLACED WITH A COMPETITOR'S DEVICE. NO SAVE TO DISK WAS DONE. AS IT WAS A COMPETITOR DEVICE REPLACEMENT, THE FIELD REPRESENTATIVE WAS UNABLE TO OBTAIN THE DEVICE FOR RETURN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT PRESENTED TO THE CLINIC DUE TO FEELING PRE-SYNCOPAL. UPON DEVICE INTERROGATION, AN ALERT WAS RECORDED (CODE 1003) INDICATING THE BATTERY VOLTAGE WAS TOO LOW FOR THE PROJECTED REMAINING CAPACITY. THE ALERT WAS CLEARED AND ANOTHER ALERT APPEARED (CODE 1007) INDICATING A CHARGE TIME EXCEEDED MESSAGE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED CLEARING THE ALERTS, THEN CHECK TO SEE IF THERE WERE ANY ADDITIONAL ALERTS. REPLACEMENT WAS RECOMMENDED AS THE PATIENT IS NOT CURRENTLY PROTECTED. THE DEVICE HAS LIMITED FUNCTIONALITY, PACING AT VVI 50 PPM. THE HEALTH CARE PROFESSIONAL (HCP) STATED SHE WOULD CHECK FOR ADDITIONAL ALERTS AND CONTACT TS WITH ANY FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384651 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWS GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R N119| 4087| 4542| 0157