BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 3071640 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05214
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MAY HAVE REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) PREMATURELY. IT WAS ALSO REPORTED THAT THE ATRIAL AND LEFT VENTRICULAR (LV) LEADS HAD HIGH THRESHOLDS. THE DEVICE AND ATRIAL LEAD WERE EXPLANTED AND REPLACED; THE LV LEAD REMAINS 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
    172474 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR D274TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR