BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3992068 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10081
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. CONCOMITANT MEDICAL PRODUCTS: C154DWK ICD, IMPLANTED: (B)(6) 2008; 6949-65 LEAD, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD CHRONIC DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR LEAD. DURING THE REPLACEMENT PROCEDURE, TWO DIFFERENT MODELS OF LEADS WERE ATTEMPTED BUT COULD NOT BE IMPLANTED DUE TO THE PATIENT'S ANATOMY. EPICARDIAL LEADS WERE IMPLANTED APPROXIMATELY ONE MONTH LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470191 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR 0185 BOSTON SCIENTIFIC LEAD