BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALLANT VR

    MDR report key: 19252149 · Received May 6, 2024

    Report

    Report Number
    2017865-2024-40466
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 15, 2024
    Report Date
    May 7, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05415067031990
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR INTERPRETED SUPRAVENTRICULAR TACHYCARDIA AS NON-SUSTAINED VENTRICULAR TACHYCARDIA. CHANGES WERE MADE TO THE PATIENT'S MEDICATION. NO FURTHER INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.

    Description of Event or Problem · 0

    INFORMATION RECEIVED INDICATES THAT THE DEVICE WAS ACTUALLY INCORRECTLY INTERPRETING NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) AS SUPRAVENTRICULAR TACHYCARDIA AND WAS NOT PROPERLY TREATING THE NSVT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576913 GALLANT VR NO MATCH NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CDVRA500Q A000140474 05415067031990

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female 7122Q/58 DURATAACTIVE LEAD.