BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 6005746 · Received October 6, 2016

    Report

    Report Number
    2649622-2016-11477
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    August 13, 2016
    Report Date
    August 13, 2016
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 5076-52 LEAD, IMPLANTED (B)(6) 2010; 0158 BOSTON SCIENTIFIC LEAD, IMPLANTED (B)(6) 2002; A7700-29 MECHANICAL VALVE, IMPLANTED (B)(6) 1996.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DOUBLE COUNTING ON THE LEFT VENTRICULAR (LV) LEAD, WHICH IS PLUGGED INTO THE RIGHT VENTRICULAR (RV) PORT IN THE DEVICE. THIS OCCURRED DUE TO THE ADDITION OF ADENOSINE POST ABLATION PROCEDURE, WHICH WAS THOUGHT TO HAVE CAUSED A WIDENING OF THE QRS COMPLEX. REPROGRAMMING WAS DONE AND 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
    661097 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention D314TRG ICD