BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA CRT-D RF HV

    MDR report key: 8466407 · Received March 29, 2019

    Report

    Report Number
    2017865-2019-04688
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    March 16, 2019
    Report Date
    May 27, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWS
    UDI-DI
    05414734508216
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    CORRECTION: SERIAL # SHOULD BE (B)(6) NOT (B)(4) , MODEL # SHOULD BE CD3369-40C NOT CD3357-40Q, LOT # , EXPIRATION DATE, UDI UPDATED. DEVICE MANUFACTURING DATE UPDATED MAR 8, 2017. PMA UPDATED SHOULD BE P910023.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS NOTED THAT RIGHT VENTRICULAR OVERSENSING WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE PATIENT WAS STABLE.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-05882. NEW INFORMATION RECEIVED NOTES THAT INTERROGATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IN CLINIC REVEALED THAT THE LEFT VENTRICULAR VECTOR HAD A HIGH CAPTURE THRESHOLD AND INTERMITTENT CAPTURE. MICRODISLODGEMENT OF THE LEFT VENTRICULAR LEAD WAS SUSPECTED. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES SERIAL NUMBER SHOULD BE (B)(4) NOT (B)(4). INFORMATION UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256460 UNIFY ASSURA CRT-D RF HV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3369-40C A000037000 05414734508216

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR