BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST PASSIVE FIXATION

    MDR report key: 4021877 · Received August 19, 2014

    Report

    Report Number
    2938836-2014-14570
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 25, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION OF THE DEVICE, OVERSENSING WAS OBSERVED ON THE VENTRICULAR CHANNEL. THE OVERSENSING COULD NOT BE REPRODUCED WITH PROVOCATIVE TESTING. THE PHYSICIAN DECIDED NOT TO TAKE ANY ACTION. THE PATIENT CONDITION WAS GOOD AND WILL UNDERGO ROUTINE FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498003 RIATA ST PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7040/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1