BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2781678 · Received October 10, 2012

    Report

    Report Number
    2649622-2012-12883
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    October 18, 2005
    Report Date
    January 1, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S030
    Removal / Correction Number
    Z-0069-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. 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 LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: "AUTOMATIC ADJUSTMENT OF STIMULATION OUTPUT IN RESYNCHRONIZATION THERAPY: IMPACT AND EFFECTIVENESS IN CLINICAL PRACTICE." (B)(4) 2011;13(9):1311-1318.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEAD. THE LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. THE LEAD WAS REPOSITIONED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. (B)(4) 2012: ADDITIONAL INFORMATION RECEIVED INDICATED THAT FIVE DAYS AFTER IMPLANT PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO RV AND LV LEAD DISLODGMENTS. BOTH LEADS HAVE BEEN REPOSITIONED. TWO DAYS LATER THE LV LEAD WAS ALSO FOUND TO BE DISLODGED; THE PHYSICIAN REPOSITIONED THE LV LEAD. APPROXIMATELY A WEEK LATER, THE PATIENT HAD DIAPHRAGMATIC STIMULATION, SO THE PHYSICIAN DECIDED TO SWITCH OFF LV STIMULATION. THE PATIENT WAS DISCHARGED ONE DAY LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6948

    Patients

    Seq Age Sex Outcome Treatment
    1 70 Hospitalization| R SENTRY IMPLANTABLE PACEMAKER/CARDIO/DEFIB