BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2810460 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15737
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 HEARD BEEPING FROM THE DEVICE FOR A NUMBER OF WEEKS BEFORE SEEING THE PHYSICIAN. THE PATIENT WAS TOLD THE LEAD WAS NOT "SEVERED" BY THE PHYSICIAN. THE DEVICE WAS REPROGRAMMED AND THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE NOTED 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 52 YR Required Intervention 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB