BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 3220009 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04268
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    April 26, 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
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD MEASURING 52.4CM FROM THE DISTAL TIP WAS RETURNED FOR EVALUATION. INTERNAL INSULATION ABRASION WAS NOTED AT 29.6-29.9CM FROM THE DISTAL TIP. INTERNAL INSULATION ABRASION UNDER THE RV SHOCK COIL WAS NOTED AT 5.0 -6.5CM FROM THE DISTAL TIP. INTERNAL INSULATION ABRASION UNDER THE RV SHOCK COIL WAS NOTED AT 29.2-29.3CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. INTERNAL INSULATION ABRASION WAS NOTED UNDER THE SVC SHOCK COIL AT 24.6-26. 6CM FROM THE DISTAL TIP. ONE RV CONDUCTOR AND THE SVC SHOCK COIL WERE MELTED AT 24.8CM FROM THE DISTAL TIP. THIS IS CONSISTENT WITH THE FIELD COMPLAINT OF LOW HV LEAD IMPEDANCE.

    Description of Event or Problem · 1

    LOW HV LEAD IMPEDANCE WAS OBSERVED. IT WAS REPORTED THAT PRIOR TO EXPLANT, X-RAY DID NOT SHOW ANY ANOMALIES. UPON EXPLANT, IT WAS REPORTED THAT THE LEAD WAS CUT AND EXTERNALIZATION WAS OBSERVED. SINCE NO ANOMALIES WERE OBSERVED PRIOR TO EXPLANT, IT IS LIKELY THAT THE REPORTED EXTERNALIZATION OBSERVED UP EXPLANT WAS DUE TO THE LEAD HAVING BEEN CUT DURING EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319776 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7021/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention