BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3080256 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-00962
    Event Type
    Death
    Date Received
    April 26, 2013
    Date of Event
    March 29, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD MEASURING 10CM WAS RETURNED FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    REVIEW OF PROVIDED DIAGNOSTICS AND EGMS INDICATED NORMAL SENSING AND NORMAL DEVICE BEHAVIOR. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE INTERROGATION, IN A CREMATORIUM ON A PATIENT WHO EXPIRED RECENTLY, THE DEVICE SHOWED UNDERSENSING IN BOTH ATRIAL AND VENTRICULAR EVENTS. THE DEVICE SHOWED A SINGLE VT/VF EVENT WHERE THE PATIENT RECEIVED ATP HOWEVER, DUE TO UNDERSENSING, THE DEVICE DETECTED A RETURN TO SINUS AND ABORTED FURTHER THERAPY. INCREASED HV AND PACING LEAD IMPEDANCE WAS NOTED. NO NEW INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183034 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death (B)(4), (B)(4)