BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 2173087 · Received July 14, 2011

    Report

    Report Number
    2173087
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    July 22, 2010
    Report Date
    August 6, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A LEAD FRACTURE AND EXPERIENCED PALPITATIONS, BUT NO DISCOMFORT. ALSO COMPLAINED OF HEARING AICD MAKE ABNORMAL SOUNDS. IT DID NOT DISCHARGE. LEAD REPLACED WITHOUT DIFFICULTY. SAME GENERATOR REPLACED. PATIENT DISCHARGED WITHOUT DIFFICULTY.======================HEALTH PROFESSIONAL'S IMPRESSION======================LEAD FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS LEAD, DEFIBRILLATION LWS MEDTRONIC, INC. 6949 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR NO OTHER THERAPIES