BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR ICD, US

    MDR report key: 6462712 · Received April 5, 2017

    Report

    Report Number
    2938836-2017-19952
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Date of Event
    February 23, 2017
    Report Date
    June 1, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PATIENT PRESENTED IN CLINIC OF A FOLLOW UP, NON-SUSTAINED OVERSENSING DUE TO T-WAVE OVERSENSING ISSUE WAS OBSERVED. PATIENT WAS ASYMPTOMATIC. OVERSENSING ISSUE WAS INTERMITTENT AND PATIENT¿S MEDICATION WAS STOPPED. PHYSICIAN ELECTED TO WAIT FOR THREE MONTHS IN HOPES THAT THE NON-SUSTAINED OVERSENSING ISSUE WILL RESOLVED ITSELF. IF ISSUE IS STILL PRESENT DURING NEXT FOLLOW UP ACTION WILL BE TAKEN. PATIENT WAS STABLE.

    Description of Event or Problem · 1

    PATIENT PRESENTED IN CLINIC WITH NON-SUSTAINED RV OVERSENSING EPISODES. PATIENT WAS ASYMPTOMATIC. PHYSICIAN ATTEMPTED TO STABILIZE THE OVERSENSING WITH MEDICATION HOWEVER WAS UNSUCCESSFUL. IT WAS SUSPECTED THAT THE OVERSENSING ISSUE WAS DUE TO POST-PACED AND POST-SENSED OVERSENSING ISSUE WHICH WAS DUE TO LEAD NOISE. ISOMETRIC TESTING WAS PERFORMED AND NOISE WAS NOT REPRODUCIBLE. LEAD REVISION WAS RECOMMENDED. PATIENT HAS MADE GOOD RECOVERY SINCE DEVICE IMPLANT PROCEDURE AND PHYSICIAN WILL CONSIDER LEAD REVISION IF NECESSARY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241998 FORTIFY ASSURA DR ICD, US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD2359-40C S000011497

    Patients

    Seq Age Sex Outcome Treatment
    1