BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 3890317 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03695
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    November 16, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO WAS PROVIDED BY MFR, 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. EVAL DESCRIPTION: THE PORTION OF THE LEAD THAT WAS RETURNED WAS NORMAL AND NO ANOMALY WAS FOUND. A COMPLETE ANALYSIS COULD NOT BE PERFORMED WITHOUT THE RETURN OF THE DISTAL PART OF THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO EVENTS OF OVERSENSING OCCURRED DUE TO NOISE IN THE VENTRICULAR CHANNEL. ONE OF THE EVENTS LEAD TO INAPPROPRIATE ATP-THERAPY. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30422 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL INC., CRMD 1570/65

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention