BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2658548 · Received July 17, 2012

    Report

    Report Number
    2182208-2012-02555
    Event Type
    Death
    Date Received
    July 17, 2012
    Date of Event
    April 1, 2012
    Report Date
    June 20, 2012
    Manufacturer
    MEDTRONIC, 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 Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE, AND NO USER FACILITY FOLLOW-UP IS POSSIBLE WITHOUT PRODUCT IDENTIFICATION. 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. WITHOUT A SERIAL NUMBER AT THIS TIME THERE IS NO WAY TO KNOW IF THIS INFORMATION HAS BEEN REPORTED ON ANOTHER MEDWATCH REPORT. (B)(4). A SINGLE-CENTRE EXPERIENCE CONCERNING THE SAFETY OF SPRINT FIDELIS DEFIBRILLATOR LEAD EXTRACTION AT THE TIME OF PULSE GENERATOR REPLACEMENT OR IN CASE OF EVIDENCE OF LEAD FAILURE. ARCHIVES OF CARDIOVASCULAR DISEASES. APRIL 1 2012;105(4):203-210.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING A HIGH VOLTAGE LEAD. MULTIPLE PATIENTS AND MULTIPLE FAILURE MODES WERE REFERENCED. THE FAILURE MODES NOTED IN THE ARTICLE WERE DEATH (SUDDEN OF UNKNOWN CAUSE), HIGH THRESHOLDS, HIGH IMPEDANCE, FRACTURE, INFECTION, AND DISLODGEMENT. THE CAUSE OF DEATH IN THE ARTICLE STATED SUDDEN AND UNKNOWN CAUSE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6949

    Patients

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