BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIFY ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 3677872 · Received March 13, 2014

    Report

    Report Number
    2938836-2014-04738
    Event Type
    Other
    Date Received
    March 13, 2014
    Date of Event
    October 2, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO WAS PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PT PRESENTED IN CLINIC DURING FOLLOW UP WITH A DEVICE THAT WAS POST PACED T-WAVE OVERSENSING ON THE VENTRICULAR LEAD. THE PT DID NOT RECEIVE THERAPY. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150662 UNIFY ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL INC., CRMD CD3257-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female