BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3781942 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-10091
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL. DATE OF EVENT UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXIT BLOCK WAS OBSERVED. THE LEAD WAS EXPLANTED. THE PATIENT CONDITION WAS GOOD AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258874 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7121/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention