BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3914619 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13152
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    February 28, 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
    TX, US
    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 PATIENT EXPERIENCED PHRENIC NERVE/DIAPHRAGMATIC STIMULATION A FEW DAYS POST IMPLANT.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE LV LEAD, A COMPETITOR PRODUCT, WAS FOUND TO BE DISLODGED AND HAD TRIGGERED THE DIAPHRAGMATIC STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391176 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122Q/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 1258T/(B)(4)