BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF VR

    MDR report key: 3880045 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03367
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    November 24, 2012
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    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 AND ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. 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 THE PT PRESENTED INTO THE EMERGENCY ROOM WITH A DEVICE THAT HAD POST SENSED T WAVE OVERSENSING. THE PT HAD RECEIVED INAPPROPRIATE THERAPY AND THE OVERSENSING WAS NOTED ON THE STORED ELECTROCARDIOGRAMS. TECHNICAL SERVICES DISCUSSED REPROGRAMMING THE POST SENSED THRESHOLD START AND POST SENSED DECAY DELAY. AN INDUCTION TEST WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25981 CURRENT RF VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CRMD 1207-36

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR