BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2781735 · Received October 11, 2012

    Report

    Report Number
    2649622-2012-12896
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    June 5, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION POST DEVICE CHANGE OUT. ANTIBIOTIC TREATMENT WAS NECESSARY. THE PREVIOUSLY CAPPED RIGHT VENTRICULAR LEAD WAS REMOVED BY EXTRACTION. POST EXTRACTION THERE WAS A TAMPONADE/EFFUSION AND THE SURGEON OPENED THE CHEST TO REMOVE THE BLOOD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R