BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1830612 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03382
    Event Type
    Death
    Date Received
    September 10, 2010
    Date of Event
    August 10, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER DUE TO MULTIPLE SHOCKS BEING DELIVERED WITH REPORTED HIGH IMPEDANCES. THE MULTIPLE SHOCKS WERE DELIVERED IN THE VT-2 AND VF ZONES. THE SHOCKS SLOWED THE RHYTHM WHILE THE PATIENT CONTINUED TO GO IN AND OUT OF VF. PATIENT WAS ADMITTED TO ICU. IT WAS LATER REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death