BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1830777 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03282
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 10, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO FOLLOW-UP WITH INCREASED HIGH VOLTAGE LEAD IMPEDANCE. ON (B)(6)2010, DURING SURGICAL PROCEDURE IT WAS NOTED THAT THE HELIX OF THE RV COIL WAS NOT EXTENDED PROPERLY. AFT ER REDEPLOYING THE HELIX, THE HVLI VALUES WERE NORMAL. THE LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention