BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ATTAIN ABILITY 4196

    MDR report key: 2100903 · Received May 18, 2011

    Report

    Report Number
    MW5020657
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    October 26, 2010
    Report Date
    May 18, 2011
    Manufacturer
    MEDTRONIC, INC
    Product Code
    OJX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BIV ICD WAS IMPLANTED ON (B)(6) 2010 W/O ANY COMPLICATIONS. HOWEVER, CHEST X-RAY PERFORMED NEXT MORNING REVEALED THAT THE LEFT VENTRICULAR LEAD HAD DEPLOYED INTO LEFT ATRIUM. THEREFORE, THE PT UNDERWENT REPOSITIONING OF THE LV LEAD WITH EXTRACTION OF OLD LEAD AND IMPLANTATION OF NEW LEFT VENTRICULAR LEAD ON (B)(6) 2010. PT WAS DISCHARGED THE NEXT DAY ON (B)(6) 2010 AFTER CXR SHOWED INTACT LEADS AND DEVICE INTERROGATION SHOWED NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ATTAIN ABILITY 4196 LEFT HEART LEAD OJX MEDTRONIC, INC 4196 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization