BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT PLUS DR

    MDR report key: 3890503 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04481
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 28, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PT HISTORY WAS OF ATRIAL PACING AT HIGH PERCENTAGE WITH CONDUCTED R WAVES. CLINICIAN NOTED ATRIAL RATE HISTOGRAM SHOWED THE WRONG PERCENT PACING AND NO COLLECTED DATA WHILE THE LIFETIME ATRIAL PACING WAS AT AN UNREASONABLE PERCENTAGE. CLINICIAN ALSO NOTED THERE WAS A LACK OF INFO IN THE HEART RATE HISTOGRAM. DEVICE WILL BE PROGRAMMED TO DDD THEN BACK TO AAI TO START COLLECTING DIAGNOSTICS NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28239 CURRENT PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD2211-36

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR