BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 3210800 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03214
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 27, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW UP, REVIEW OF RECORDS SHOWED SEVERAL EPISODES OF NOISE. EXTERNALIZED CONDUCTORS WERE OBSERVED VIA X-RAY. NO ELECTRICAL ANOMALIES WERE DETECTED. LEAD REMAINS IMPLANTED AND FOLLOW UP HAS BEEN SCHEDULED. IT WAS LATER REPORTED THAT THE PATIENT STOPPED USING HER CLOCK-RADIO AND THE NOISE DISAPPEARED. THE PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311387 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1