BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1223625 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03589
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 28, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE VENTRICULAR LEAD. AS A RESULT, INAPPROPRIATE SHOCKS WERE DELIVERED. THE LEAD IMPEDANCE WAS WITHIN NORMAL LIMITS AND ISOMETRICS DID NOT PROVOKE ANY NOISE ON THE LEAD. THE LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention