BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1874928 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11601
    Event Type
    Injury
    Date Received
    October 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD DID NOT HAVE CAPTURE AT MAX OUTPUTS. THE LEAD WAS CAPPED. NO PATIENT COMPLICATIONS WERE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB