BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 4051620 · Received September 2, 2014

    Report

    Report Number
    2938836-2014-15313
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    June 3, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASION WAS NOTED AT 42.6-43.1CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE SILICONE INSULATION WAS INTACT AT THIS LOCATION.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAPTURE ANOMALY WAS OBSERVED. IT WAS NOTED THAT THE LEAD WAS IMPLANTED ON THE MODERATOR BAND CAUSING VT EPISODES. THE LEAD WAS EXPLANTED FOR VT ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533911 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention