BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1895676 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04485
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 17, 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 Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED OTHER TEXT : NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOSS OF CAPTURE AND LOW SENSING WERE OBSERVED. THE PHYSICIAN ELECTED TO EXPLANT THE LEAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention