BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 3160436 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07975
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    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: 5076-45, (B)(6) 2008; 6947 IMPLANTABLE TACHY LEAD (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY REMOTE TRANSMISSION THE ATRIAL LEAD REVEALED UNDER SENSING ON A STORED DIAGNOSTIC. IT WAS ALSO NOTED THE LEFT VENTRICULAR (LV) LEAD THRESHOLD HAD INCREASED GREATER THAN THE PROGRAMMED SAFETY MARGIN. THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259418 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR