BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDANT

    MDR report key: 751726 · Received August 14, 2006

    Report

    Report Number
    751726
    Event Type
    Injury
    Date Received
    August 14, 2006
    Date of Event
    August 11, 2006
    Report Date
    August 11, 2006
    Manufacturer
    GUIDANT
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BATTERY VOLTAGE SHOWED SUDDEN DECLINE FROM BOL 3.07 VOLTS ON 4/17/2006 TO ERI ON 5/8/2006. NO SHOCKS BY ICD. PACING APPROX 5-13% HISTORICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT ICD GENERATOR LWS GUIDANT 1860 *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R