BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3905383 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10412
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P010012/S165
    Removal / Correction Number
    Z-0025-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382320 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP BOSTON SCIENTIFIC CORPORATION N119 038007

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| L| H 0185| 4087| 4543| N119| 4543| 4087| 0185| N119