BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 3153427 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06005
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: D274TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2011; 6949 IMPLANTABLE TACHY LEAD (B)(6) 2006; 5568 IMPLANTABLE PACING LEAD (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT TRIGGERED FOR THE LEFT VENTRICULAR (LV) LEAD DUE TO HIGH SHORT INTERVAL COUNTS AND A SHORT EPISODE THAT APPEARED TO BE NOISE. IT WAS NOTED THAT THE LV LEAD DURING A PREVIOUS DEVICE CHANGE OUT HAD BEEN PLUGGED INTO THE RIGHT VENTRICULAR PACE/SENSE PORT OF THE DEVICE. TROUBLE SHOOTING WITH ISOMETRICS AND POCKET MANIPULATION WAS DONE BUT THE NOISE COULD NOT BE REPEATED. THE LV LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258809 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR