BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST PASSIVE FIXATION LEAD

    MDR report key: 1073600 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02484
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 26, 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

    FINAL ANALYSIS FOUND NORMAL EELCTRICAL CHARACTERISTICS. THE LEAD WAS CUT/DAMAGED. THE DAMAGE IS CONSISTENT WITH THAT OCCURRING DURING THE SURGICAL PROCEDURE. ANALYSIS OF PROVIDED PRINTOUTS SHOWED A HIGH CAPTURE THRESHOLD, A LOW SENSING AMPLITUDE, AND NORMAL LEAD IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED LOSS OF SENSING AND A HIGH CAPTURE THRESHOLD. X-RAY DID NOT REVEAL DISLODGEMENT. THE DEVICE WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention