BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM PASSIVE FIXATION LEAD

    MDR report key: 1050918 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01857
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 18, 2008
    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 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 AT FOLLOW-UP, THE PATIENT COMPLAINED OF TWITCHING. MEASURED DATA SHOWED UNDERSENSING AND A DROP IN IMPEDANCE. THRESHOLD COULD NOT BE CAPTURED AND THE TWITCHING WAS INDUCED DURING PACING. A PERFORATION WAS CONFIRMED BY X-RAY, ULTRASONOGRAPHY AND CT. AT EXPLANT, AN INFECTION WAS ALSO NOTED. THE LEAD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM PASSIVE FIXATION LEAD NO BNCN FOUND FOR THIS DEVICE LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7070/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention