BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2791387 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14522
    Event Type
    Injury
    Date Received
    October 15, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH SUPERIOR VENA CAVA (SVC) LEAD IMPEDANCE DURING DEVICE REPLACEMENT. IT WAS ALSO REPORTED THAT THE RV LEAD WAS ASSUMED TO BE DAMAGE DURING DEVICE REPLACEMENT BECAUSE THERE WAS DIFFICULTY IN REMOVING THE DEVICE FROM THE PATIENT'S BODY, AND THE RV LEAD WAS SUSPECTED OF STRESS DURING STRIPPING OF THE ADHESION. IT WAS FURTHER REPORTED THAT THE SVC PORTION OF THE RV LEAD WAS ABANDONED AND THE DEFIBRILLATION MODE OF THE RV LEAD WAS CHANGED FROM CAN TO RV DUE TO SUCCESSFUL DEFIBRILLATION THRESHOLD (DFT) TESTS. THE RV LEAD REMAINS IN USE. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. NO 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 67 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD