BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION LEAD

    MDR report key: 3890373 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03625
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    November 27, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION DESCRIPTION INCLUDED. A PARTIAL LEAD WAS RETURNED CUT IN TWO SECTIONS. ONE SECTION OF LEAD FROM THE CONNECTOR PIN MEASURING 26.3CM AND OTHER SECTION FROM THE TIP ELECTRODE MEASURING 39.0CM. THE PORTION OF THE LEAD THAT WAS RETURNED WAS NORMAL. THE REPORTED FIELD EVENT OF RESISTANCE TOO HIGH/HIGH IMPEDANCE WAS UNABLE TO CONFIRM DUE TO CONDITION OF LEAD AS RECEIVED. THE DAMAGE FOUND IS CONSISTENT WITH THAT OCCURRING AT THE TIME OF EXPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD WAS EXPLANTED DUE TO HIGH PACING LEAD IMPEDANCE. DURING PROCEDURE, THE ATRIAL LEAD WAS DAMAGED AND WAS EXPLANTED TOO. DEVICE WAS UPGRADED TO BI VENTRICULAR ICD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31420 RIATA ST OPTIM ACTIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL INC., CRMD 7021/65

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention