BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 3994283 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10099
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 27, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE 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
    468660 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419388

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR 694765 LEAD