BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3801350 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10908
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    February 11, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    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 WHEN AN ASYMPTOMATIC PATIENT PRESENTED FOR ROUTINE FOLLOW UP, NON-SUSTAINED LEAD NOISE WAS OBSERVED ON STORED EMG. NOISE WAS NOT REPRODUCIBLE WITH ISOMETRIC AND ARM MOVEMENTS. NO ELECTRICAL MEASUREMENT ANOMALIES WERE DETECTED. REVIEW OF PREVIOUS FLUOROSCOPY WAS INCONCLUSIVE. THE LEAD REMAINS IMPLANTED AND PATIENT WILL BE MONITORED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT VENTRICULAR SENSING HAS BEEN STEADILY DECREASING. POSSIBLE LEAD INSULATION BREACH WAS SUSPECTED. LEAD REPLACEMENT WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278871 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR (B)(4)