BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3914585 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13148
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 11, 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 Location
    CA
    Reporter Occupation
    PHYSICIAN

    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 DEVICE HAD MIGRATED IN THE BODY. PATIENT FELT PAIN AND DISCOMFORT. SYSTEM WAS EXPLANTED PER PATIENTS REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390546 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention CD1233-40, 819167