BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 1223163 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03727
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 11, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    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

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT NOTIFIER ALERTED THE PATIENT. HIGH SVC-CAN AND RV-SVC IMPEDANCES WERE NOTED. LOOSE SETSCREW WAS SUSPECTED. THE PATIENT'S DEVICE WAS REPROGRAMMED TO RV-CAN. THE PATIENT WAS SCHEDULE FOR POCKET REVISION DUE TO PAINFUL POCKET. THE DEVICE WAS TESTED POST POCKET-REVISION AND THE SVC-CAN AND RV-SVC IMPEDANCE WAS STILL HIGH. THE DEVICE WAS LEFT PROGRAMMED TO RV-CAN. SINCE DFT WAS NORMAL, THE SYSTEM REMAINS 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