BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 3286322 · Received August 14, 2013

    Report

    Report Number
    2182208-2013-02559
    Event Type
    Death
    Date Received
    August 14, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 18, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE DATE OF DEATH USED, IS PURELY AN ESTIMATE, AS THERE IS NO SPECIFIC PATIENT INDICATED AND NO ACTUAL LEAD-DEATH RELATEDNESS INDICATED. CORRESPONDENCE WAS CONDUCTED WITH THE ARTICLE CONTACT PERSON. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: MULTI-INSTITUTIONAL STUDY OF IMPLANTABLE DEFIBRILLATOR LEAD PERFORMANCE IN CHILDREN AND YOUNG ADULTS RESULTS OF THE PEDIATRIC LEAD EXTRACTABILITY AND SURVIVAL EVALUATION (PLEASE) STUDY. CIRCULATION. JUNE 18 2013;127(24):2393-2402. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD MODEL. MULTIPLE PATIENTS AND MULTIPLE FAILURE MODES WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. THE FAILURE MODES NOTED WERE: DEATHS (CAUSES INDICATED FAILED APPROPRIATE SHOCKS, REFRACTORY VENTRICULAR ARRHYTHMIA, PULSELESS ELECTRIC ACTIVITY AFTER SUCCESSFUL DEFIBRILLATION, END-STAGE VENTRICULAR DYSFUNCTION, STROKE AND A NON-CARDIAC CAUSE; HOWEVER, NO DIRECT DEATH-LEAD RELATEDNESS WAS INDICATED), FRACTURE, INAPPROPRIATE SHOCKS, EXTRACTION COMPLICATIONS (¿SUPERIOR VENA CAVA PERFORATION, INNOMINATE VEIN TEAR, BLEEDING AND TRANSIENT HYPOTENSION, AND NEW-ONSET MODERATE TRICUSPID REGURGITATION AFTER EXTRACTION¿). FURTHER FOLLOW UP DID NOT YIELD ANY ADDITIONAL INFORMATION. THE STATUS OF THE LEAD IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392067 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R