BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3153347 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05951
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. ANALYSIS REVEALED THAT THE DISTAL CONDUCTOR OF THE LEAD WAS EXTRINSICALLY OVER-ROTATED AND THE DISTAL LOW VOLTAGE ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH. ADDITIONALLY, VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED THERE WAS APPARENT EXPLANT DAMAGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROPHYLACTIC RIGHT VENTRICULAR (RV) LEAD CHANGE-OUT PROCEDURE, THE PHYSICIAN ATTEMPTED TO RETRACT THE HELIX WITHOUT A STYLET. AFTER MULTIPLE TURNS AND NO RETRACTION, THE PHYSICIAN TRIED TO INSERT A STYLET BUT COULD NOT ADVANCE THE STYLET THROUGH THE TERMINAL PIN OF THE LEAD. THE RV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258010 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD