BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2842798 · Received November 15, 2012

    Report

    Report Number
    2842798
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED MULTIPLE DEFIBRILLATOR FIRINGS WITH COMPLAINT OF MODERATE PAIN AND DIZZINESS. CAME TO HOSPITAL VIA PARAMEDICS. KNOWN LEAD FRACTURE - EXCHANGED. GENERATOR PROHYLACTICALLY CHANGED AT SAME TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS LEAD, ICD, RV LWS MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 6949-65 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R