BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF VR

    MDR report key: 3890212 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04470
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    November 2, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POSSIBLE OUTPUT CIRCUIT DAMAGE ALERT FOR THE DEVICE OF AN ASYMPTOMATIC PATIENT. THE PATIENT HAD UNDERGONE HEART BYPASS SURGERY, DURING WHICH TIME HV THERAPY WAS NOT TEMPORARILY SUSPENDED. THE PATIENT RECEIVED HV SHOCKS DURING THE PROCEDURE. THE ISSUE WAS RESOLVED NON INVASIVELY BY REDOWNLOADING DEVICE FIRMWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34365 CURRENT RF VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS LWS ST. JUDE MEDICAL INC., CRMD 1207-36

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention