BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1071913 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03739
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    October 15, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0069-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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

    THE PATIENT REPORTED HIS IMPLANTED LEAD "WENT BAD" AND WAS, SUBSEQUENTLY, REPLACED. IT WAS FURTHER REPORTED THAT THE LEAD WAS EXPLANTED AND REPLACED DUE TO INFECTION. NO FURTHER 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. 6948 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D153VRC IMPLANTABLE PACEMAKER/CARDIO/DEFIB