BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 1830559 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03204
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 5, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    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 DEVICE DETECTED SEVERAL EPISODES OF VF AND VT DUE TO T-WAVE OVERSENSING. THE PHYSICIAN DECIDED TO REPROGRAM THE DEVICE. HOWEVER, IT WAS NOTED THAT REPROGRAMMING WILL NOT RESOLVE THE ISSUE. IT WAS RECOMMENDED TO CONSIDER REPLACING THE SENSE/PACE LEAD OR REPOSITION THE LEAD TO POSSIBLY HAVE BETTER R-WAVE SENSING. THE SYSTEM REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS CAPPED DUE TO A SUSPECTED FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention