BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 1050972 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01906
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    December 7, 2007
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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

    THE PATIENT REPORTED THAT ALERTS HAD BEEN ISSUED BY THE PATIENT NOTIFIER. IT WAS OBSERVED THAT A LOW IMPEDANCE MEASUREMENT WAS REPORTED. LOSS OF CAPTURE AT MAXIMUM OUTPUT WAS ALSO SEEN. IN ADDITION, THE PATIENT'S R-WAVE SIGNAL AMPLITUDE DECREASED SIGNIFICANTLY. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED WHEN A PERFORATION WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM ACTIVE FIXATION NO BNCN FOUND FOR THIS DEVICE LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7020/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention