BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY ASSURA ICD

    MDR report key: 6174276 · Received December 14, 2016

    Report

    Report Number
    2938836-2016-17386
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    October 23, 2016
    Report Date
    September 20, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT FOR NON-SUSTAINED RV OVERSENSING WAS RECEIVED VIA REMOTE TRANSMISSION. REVIEW OF THE EPISODES, SHOWS LEAD NOISE AS WELL AS AN EPISODE OF POSSIBLE MYOPOTENTIAL OVERSENSING AND FURTHER TESTING WAS RECOMMENDED. THE PATIENT WAS BROUGHT INTO THE CLINIC, ISOMETRIC TESTING PREFORMED AND NO NOISE WAS NOTED. THE PATIENT WILL CONTINUE TO BE MONITORED ON MERLIN.NET.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTED THAT WHEN THE PATIENT PRESENTED TO THE CATH LABE FOR POSSIBLE RV LEAD REPLACEMENT., THERE WAS NO VASCULAR ACCESS TO IMPLANT NEW LEAD, IN LIGHT OF THIS THE LEAD WAS MANIPULATED AND THERE WERE NO SIGNS OF NOISE. THE ELECTRICAL PARAMETERS WERE UNCHANGED AND STABLE. THE PHYSICIAN ELECTED TO LEAVE THE LEAD INTACT AND CHANGE THE DEVICE INSTEAD. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. THE PATIENT WAS STABLE PRE, DURING AND POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823537 UNIFY ASSURA ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3361-40C S000010856

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 7020/65, (B)(4)