BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 2952513 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00591
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 7, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    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. PRODUCT: 4574 IMPLANTABLE PACING LEAD (B)(6) 2011; 6947 IMPLANTABLE TACHY LEAD (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S RELATIVE CALLED TO REPORT THE DEVICE BATTERY WAS VERY LOW AND HAD FEW MONTHS LEFT. FOLLOW UP CONFIRMED THAT THE PATIENT WAS BEING MONITORED CLOSELY FOR DEVICE BATTERY LIFE. IT WAS NOTED THAT THERE WAS HIGH THRESHOLDS ON ALL THREE OF THE PATIENT'S LEADS AND THE DEVICE HAD DRAMATICALLY DECREASED IN VOLTAGE. THE CUSTOMER SUSPECTS A LEAD EXIT BLOCK RELATING TO THIS ISSUE. THE DEVICE AND 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
    57182 ATTAIN OTW ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR D274TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR