BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT RF VR

    MDR report key: 4092172 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05012
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    September 29, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF NOISE WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF STORED ELECTROGRAMS. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND NO ANOMALY WAS FOUND. THE CAUSE OF THE NOISE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED DURING IMPLANT OF A NEW LEAD. THE SOURCE OF THE NOISE COULD NOT BE DETERMINED, SO THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD AND THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22515 CURRENT RF VR LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 1207-36

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR (B)(4)