BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA VR ICD_O_US

    MDR report key: 5394338 · Received January 27, 2016

    Report

    Report Number
    2938836-2016-00519
    Event Type
    Injury
    Date Received
    January 27, 2016
    Date of Event
    January 11, 2016
    Report Date
    October 10, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: PMA/510(K) # - P910023.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REPORT 2938836-2016-00519 AND ALL ASSOCIATED FOLLOW-UPS SHOULD NOT HAVE BEEN REPORTED AS A MEDICAL DEVICE REPORT (MDR) AS THE PRODUCT HAS NOT BEEN APPROVED BY FDA AND IS PART OF INVESTIGATION DEVICE EXEMPTION (IDE).

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT PREVIOUSLY DEVICE WAS REPROGRAMMED TO SOLVE THE ISSUE. HOWEVER, POST-SENSED OVERSENSING CONTINUED TO OCCUR DURING PERIODS OF DIMINISHED R-WAVE AMPLITUDES. PATIENT WAS ASYMPTOMATIC. RECOMMENDED ADDITIONAL PROGRAMMING CHANGES WERE MADE. FURTHER DEVICE REPROGRAMMING WAS SUGGESTED. PATIENT WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC DURING FOLLOW-UP POST-SENSED T-WAVE OVERSENSING WAS OBSERVED ON STORED EGM. THE PATIENT RECEIVED INAPPROPRIATE ANTITACHYCARDIA PACING THERAPY AND HV THERAPY. DECREASE IN R-WAVE AMPLITUDE MEASUREMENT WAS ALSO NOTED. PROGRAMMING CHANGES WERE MADE. PATIENT WILL BE MONITORED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT AFTER PROGRAMMING CHANGES, AN EPISODE OF T-WAVE OVERSENSING WAS OBSERVED. PROGRAMMING CHANGES WERE RECOMMENDED. PATIENT WAS STABLE.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT WHEN THE ASYMPTOMATIC PATIENT PRESENTED DURING ROUTINE FOLLOW-UP, POST-SENSED T-WAVE OVERSENSING WAS OBSERVED AGAIN ON STORED EGM. IN ONE EPISODE, UNDERSENSING WAS ALSO NOTED. IT WAS DISCUSSED THAT THE R-WAVE IS TOO SMALL TO PROGRAM AROUND. THERAPIES WERE TURNED-OFF. SINCE THE PATIENT¿S EF HAS BEEN IMPROVED, PLAN IS TO PERFORM ECHO AGAIN, REMOVE THE DEVICE, AND CAP THE LEADS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50760 FORTIFY ASSURA VR ICD_O_US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD1259-40Q 4368489

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention