BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 11991056 · Received June 14, 2021

    Report

    Report Number
    11991056
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    November 6, 2020
    Report Date
    May 26, 2021
    Manufacturer
    BOSTON SCIENTIFIC CRM CORP
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ALERT FROM LATITUDE FOR 1003 FAULT CODE (VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY). BSC TECH SUPPORT RECOMMENDED GENERATOR CHANGE WITHIN 90 DAYS. ICD GENERATOR CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888753 TELIGEN IMPLANTABLE CARDIAC DEFIBRILLATOR LWP BOSTON SCIENTIFIC CRM CORP E102

    Patients

    Seq Age Sex Outcome Treatment
    1 15695 DA