BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3160329 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07938
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT EVENT SUMMARY #(B)(4). THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. HOWEVER, THE PROXIMAL AND DISTAL LV (LOW VOLTAGE) ELECTRODES OF THE LEAD WERE COVERED IN BODY TISSUE/FIBROTIC GROWTH. THE DISTAL DEFIBRILLATOR ELECTRODE WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. (B)(4): PRODUCT ID D154ATG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  IMPLANTED: 2006-(B)(6), PRODUCT ID 5076 IMPLANTABLE PACING LEAD IMPLANTED: 2006-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE SHORT V-V INTERVALS OBSERVED IN THE RIGHT VENTRICULAR (RV) LEAD AND POSSIBLE EARLY FAILURE OF THE LEAD. DURING THE PROCEDURE TO REMOVE THE RV LEAD, THE HELIX WOULD NOT RETRACT AND THE LEAD WAS EXTRACTED VIA LASER. IT WAS FURTHER REPORTED THAT DURING THE LASER EXTRACTION THE RIGHT ATRIAL (RA) LEAD WAS ENTANGLED WITH THE RV LEAD AND INADVERTENTLY "PULLED OUT".THE RV LEAD AND RA LEAD WERE REMOVED AND REPLACED WITH NEW LEADS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259816 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R