BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM PASSIVE FIXATION LEAD

    MDR report key: 1073196 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02548
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 16, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. THE LEAD EXHIBITED NO MECHANICAL OR VISUAL ANOMALIES. THE SUTURE SLEEVE WAS MEASURED AND ALL MEASURED VALUES WERE WITHIN PRODUCT SPECIFICATION. ELECTRICAL TESTING WAS PERFORMED ON THE LEAD AND THE RESULTS INDICATED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    AFTER THE LEAD WAS IMPLANTED, THE LEAD SLIPPED OFF AND WAS PULLED DUE TO THE SLICK SURFACE OF THE SUTURE SLEEVE. THE POCKET WAS REOPENED TO TIGHTEN THE STRING OF THE SUTURE SLEEVE. HOWEVER, THE LEAD SLIPPED OFF AGAIN. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM PASSIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7070/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention