BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION LEAD

    MDR report key: 1050961 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01900
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 26, 2007
    Report Date
    March 29, 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
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER AND A MEDWATCH FORM WAS RECEIVED E3/G3 - RISK MANAGER.

    Description of Event or Problem · 1

    THE LEAD WAS EXPLANTED DUE TO AN INCREASE IN CAPTURE THRESHOLD. THE PHYSICIAN SUSPECTED A HELIX ANOMALY. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7001/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention