BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 4162065 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11639
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 3, 2014
    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: 694765 LEAD, IMPLANTED: (B)(6) 2010; 5076-52 LEAD, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT TRIGGERED DUE TO HIGH RIGHT VENTRICULAR (RV) DEFIBRILLATION IMPEDANCE. THE RV AND SUPERIOR VENA CAVA (SVC) IMPEDANCES HAVE BEEN UNSTABLE AND THE SVC HAS ALSO BEEN HIGH. THE LEFT VENTRICULAR (LV) LEAD HAS ALSO EXHIBITED AN IMPEDANCE FLUCTUATION OVER THE SAME PERIOD OF TIME. THE LEADS REMAIN 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
    643970 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR D224TRK ICD