BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3192514 · Received June 27, 2013

    Report

    Report Number
    2649622-2013-08146
    Event Type
    Death
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. CONCOMITANT PRODUCTS: (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTED: 2010 (B)(6); 419688 IMPLANTABLE PACING LEAD IMPLANTED: 2010 (B)(6); 693565 IMPLANTABLE TACHY LEAD IMPLANTED: 2010 (B)(6). (B)(4).

    Description of Event or Problem · 1

    A CALL WAS RECEIVED FROM THE CLINICIAN REQUESTING REVIEW OF A REMOTE MONITOR TRANSMISSION. THE TRANSMISSION OCCURRED DUE TO TRIGGERING OF A LEAD INTEGRITY ALERT (LIA). DURING THE CONVERSATIONS IT WAS REPORTED THAT THE PATIENT IS DECEASED. TECHNICAL SERVICE REVIEW OF THE TRANSMISSION WITH THE CLINICIAN NOTED THAT THE PATIENT HAD VENTRICULAR FIBRILLATION (VF) AND RECEIVED SIX SHOCKS WITHOUT SUCCESSFULLY TERMINATING THE RHYTHM. THE LIA IS NOTED TO BE DUE TO NONPHYSIOLOGIC SENSING AND ELEVATED SHORT INTERVAL COUNTS (SIC). ADDITIONAL INFORMATION RELATED TO THE CAUSE OF DEATH AND CIRCUMSTANCES OF DEATH HAVE BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294284 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO OPERATIONS CO 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Death