BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 4140447 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17586
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 8, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD REPRESENTATIVE INFORMED THAT THE DEVICE WOULD NOT LIKELY BE RETURNED AS THE HOSPITAL RETAINS DEVICES AFTER THEY ARE EXPLANTED. SHOULD THE DEVICE GET RETURNED AT A LATER DATE, THIS REPORT WOULD BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HEARD BEEP TONES FROM THEIR DEVICE AFTER IT WAS CHECKED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED REASON FOR BEEP TONES IF THE DEVICE REACHES EXPLANT STATUS OR HAS ISSUED AN ALERT. THE CALLER CONFIRMED A REPLACEMENT HAS BEEN SCHEDULED FOR THE FOLLOWING WEEK.

    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 EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617745 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 4555| 0175| 4469| N119