BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 1895550 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04269
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 3, 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. OTHER: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE ABORTED VF THERAPIES. SUSPECTED INSULATION BREAK. THE LEAD REMAINS IMPLANTED.

    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 1571/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1