BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3801363 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10931
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    November 15, 2010
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH RV CAPTURE THRESHOLD AND NOISE WAS OBSERVED ON RV LEAD. LEAD FRACTURE WAS ALSO NOTED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279264 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention