BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST PASSIVE FIXATION

    MDR report key: 3854675 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11590
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 9, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED THAT DEVICE INTERROGATION REVEALED BI-V PACING INHIBITION DUE TO OVERSENSING ON THE VENTRICULAR CHANNEL. THE PHYSICIAN ELECTED TO CAP AND REPLACE THE PACE/SENSE PORTION OF THE LEAD. A NEW LEAD COULD NOT BE IMPLANTED DUE TO A PROBLEM WITH THE VEIN. THE PHYSICIAN USED A PREVIOUSLY CAPPED PACE/SENSE LEAD INSTEAD. THE DEFIB PORTION OF THE CHRONIC LEAD REMAINED ACTIVE. DFTS WERE SUCCESSFUL AFTERWARD. THE PATIENT CONDITION WAS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331008 RIATA ST PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7042/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention