BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3911062 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-12992
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 2, 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
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. A PARTIAL LEAD WITH THE DISTAL PORTION MEASURING 41.0CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 13.5-14.0CM FROM THE DISTAL END. THE ETFE COATING WAS INTACT AT THIS LOCATION. EXTERNAL INSULATION ABRASION WAS NOTED AT 7.0-8.0CM FROM THE DISTAL END. THE ETFE COATING WAS ABRADED AT THIS LOCATION. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO NOISE. LEAD WAS EXPLANTED. PATIENT WAS WELL AFTER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385825 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention