BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION

    MDR report key: 1932370 · Received December 17, 2010

    Report

    Report Number
    2017865-2010-05415
    Event Type
    Death
    Date Received
    December 17, 2010
    Date of Event
    December 1, 2010
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    INCORRECT SERIAL NUMBER INITIALLY REPORTED. SERIAL NUMBER SHOULD BE: (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTES THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE LEADS WERE IN PLACE AND THE PATIENT SUDDENLY EXPERIENCED VF AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7170/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death 1258T/86, (B)(4), 1642T/52, (B)(4)