BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3220195 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04342
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    April 22, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASION WAS NOTED AT 38.0-38.3CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE SILICONE INSULATION WAS INTACT AT THE SAME LOCATION.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED EXTERNAL INSULATION ABRASION WAS NOTED AT 38.0-38.3CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS INTACT AT THIS LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER EXPERIENCING POCKET STIMULATION. RV THRESHOLDS WERE INCREASED, R-WAVES HAD DECREASED AND IMPEDANCE WAS TRENDING DOWN. NOISE WAS REPRODUCIBLE DURING ARM MOVEMENTS. THE POCKET WAS OPENED AND AN INSULATION ABRASION ON THE PACE/SENSE PORTION OF THE LEAD WAS OBSERVED. DURING LASER LEAD EXPLANT PROCEDURE, THE ATRIAL LEAD PULLED BACK AND WAS REPLACED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321298 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7122/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention