BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL

    MDR report key: 471263 · Received July 10, 2003

    Report

    Report Number
    471263
    Event Type
    Injury
    Date Received
    July 10, 2003
    Date of Event
    April 17, 2003
    Report Date
    May 7, 2003
    Manufacturer
    ST. JUDE MEDICAL CO
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS SEEN IN THE OUTPATIENT DEVICE CLINIC AND THE ICD WAS AT EARLY ELECTIVE REPLACEMENT INDICATOR AS INDICATED BY PROLONGED CHARGE TIMES OF >25 SECONDS. PT WAS ADMITTED. ICD DEVICE REPLACEMENT WITHOUT COMPLICATION. THE MALFUNCTIONING DEVICE WAS EXPLANTED AND SENT TO THE MFR FOR EVALUATION. THE PT WAS DISCHARGED AND IS SCHEDULED TO COME TO THE OUTPATIENT DEVICE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL ICD GENERATOR LWS ST. JUDE MEDICAL CO V-230 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization