BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 5863138 · Received August 9, 2016

    Report

    Report Number
    2649622-2016-10659
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    June 7, 2016
    Report Date
    June 7, 2016
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 694965, LEAD, 407652 LEAD, IMPLANTED: (B)(6) 2006.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS WORKING ON AN ELECTRICAL BOX AND EXPERIENCE A LIA AGAIN. IT WAS ALSO NOTED THAT LEFT VENTRICULAR (LV) LEAD HAD EXHIBITED A HIGH PACING IMPEDANCE. 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
    515772 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419388

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening