BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 1050652 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01614
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 14, 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 Location
    SC
    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 1 DAY POST IMPLANT, R-WAVE AMPLITUDES DECREASED AND NOISE WAS OBSERVED ON THE RV LEAD. THE NOISE WAS REPRODUCIBLE WITH ARM MOVEMENT. THE PATIENT ADMITTED TO THE ER THE FOLLOWING DAY AFTER RECEIVING TWO VIBRATORY ALERTS DUE TO HIGH LEAD IMPEDANCE. IT WAS DETERMINED THAT A SETSCREW ON THE DEVICE HEADER WAS LOOSE. THIS ISSUE WAS RESOLVED BY RE-INSERTING THE LEAD INTO THE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT RF DR NO BNCN FOUND FOR THIS DEVICE LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention