BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST PASSIVE FIXATION

    MDR report key: 1830662 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03352
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 12, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 UPON INTERROGATION, RV LEAD IMPEDANCE MEASUREMENTS AND CAPTURE THRESHOLD HAD INCREASED. THE PATIENT DID NOT RECEIVE ANY INAPPROPRIATE THERAPY. ISOMETRICS, POCKET MANIPULATION AND POSITIONAL TESTING AND COULD NOT PRODUCE THE NOISE. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST PASSIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7040/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention