BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC CORP.

    MDR report key: 7171486 · Received January 5, 2018

    Report

    Report Number
    MW5074441
    Event Type
    Injury
    Date Received
    January 5, 2018
    Date of Event
    January 4, 2018
    Report Date
    January 4, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOUR YEARS AFTER CRT-D IMPLANT (PULSE GENERATOR BSC N161 SN (B)(4)) THE DEVICE DEVELOPED A PROBLEM ASSESSING ITS OWN BATTERY: UNSCHEDULED LATITUDE REMOTE TRANSMISSION TRIGGERED FOR BATTERY VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY. CODE 1003. WILL CONTACT LATITUDE CUSTOMER SUPPORT AS SOON AS THEY ARE OPEN (7 AM CENTRAL TIME) TO GET SPECIFIC BATTERY VOLTAGE. LAST REMOTE IN (B)(6) SHOWED GREATER THAN 5 YEARS. MD NOTIFIED OF BATTERY STATUS. CONTACTED TECH SUPPORT FOR BOSTON SCIENTIFIC FOR SPECIFIC BATTERY LIFE AND SUGGESTED REPLACEMENT TIME FOR PATIENT'S DEVICE. TECH SUPPORTED STATED DEVICE SHOULD BE CHANGED OUT IN NEXT 28 DAYS AND EXPLANTED DEVICE RETURNED TO COMPANY. NOTIFIED MD OF ABOVE NOTIFICATION. N161.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14136 BOSTON SCIENTIFIC CORP. CRT-D IMPLANT LWS BOSTON SCIENTIFIC CORP. N161

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention