BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4030779 · Received August 22, 2014

    Report

    Report Number
    2938836-2014-14733
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    July 19, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE DISTAL TIP MEASURING 64.3CM WAS RETURNED FOR ANALYSIS. THE LEAD WAS RETURNED WITHOUT THE CONNECTOR PIN. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT PRIOR TO EXPLANT, LEAD DISLODGEMENT WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DISCHARGE CHECK, RV LOSS OF CAPTURE WAS OBSERVED. THE LEAD WAS SUCCESSFULLY REPOSITIONED. AFTER RE-INSERTING THE LEAD INTO THE DEVICE HEADER, THE LEAD PULLED OUT DURING A TUG TEST. IT WAS NOTED THAT THE LEAD PIN BROKE OFF AND WAS STUCK IN THE DEVICE HEADER. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS DOING WELL FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509999 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7121Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention CD3365-40Q, 7122224