BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1013371 · Received March 10, 2008

    Report

    Report Number
    2649622-2008-00957
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    November 19, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0067-007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVERSENSING WAS NOTED. THE PATIENT DID NOT RECEIVE ANY INAPPROPRIATE THERAPIES. LEAD REPLACEMENT WAS PLANNED. FOLLOW-UP INFORMATION RECEIVED INDICATES THE LEAD IS STILL IN USE. IT WAS SUCCESSFULLY REPOSITIONED ON 20-NOV-2007, BUT WAS NOT REPLACED. THE PATIENT NOW HAS ROUTINE FOLLOW-UP EVERY THREE MONTHS. 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. 6948 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD