BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4153635 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16520
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 23, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INCREASED CAPTURE THRESHOLD WAS OBSERVED. LEAD WAS EXPLANTED AND REPLACED WHEN REPOSITIONING WAS UNSUCCESSFUL.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES LEAD DISLODGEMENT WAS ALSO OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631728 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention