BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT RF VR

    MDR report key: 3881178 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02200
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    January 29, 2013
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 POST SENSED T WAVE OVERSENSING WAS OBSERVED. THE DEVICE WAS ALSO INTERMITTENTLY UNDERSENSING R WAVES. REPROGRAMMING WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30286 CURRENT RF VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CRMD 1207-36

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR