BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 1954735 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00136
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 2, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 PATIENT NOTIFIER ALERT SHOWED THE HIGH VOLTAGE LEAD IMPEDANCE WAS OUT OF RANGE. THE PHYSICIAN OPENED THE POCKET AND RE-TIGHTENED THE SCREWS AND CHECKED THE INTEGRITY OF THE LEAD. THE IMPEDANCE ISSUE WAS RESOLVED. THE PHYSICIAN ALLEGES THAT THE EVENT WAS CAUSED BY THE IMPROPER TIGHTENING OF THE RV SCREW. THE DEVICE AND LEADS REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention