BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1091563 · Received August 1, 2008

    Report

    Report Number
    3004209178-2008-04597
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 2, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD MIGRATED RESULTING IN PAIN AROUND THE LEADS AND EXTENSIONS. THE PT EXPERIENCED NO STIMULATION SENSATION SINCE 2008. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. THE PT WAS AT HOME AT THE TIME OF THE COMPLAINT. THE PATIENT'S HCP WAS NO LONGER AVAILABLE FOR CONSULTATION; SHE WAS PROVIDED WITH PHYSICIAN LISTINGS. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| IMPLANTED| EXPLANTED| LEAD MODEL 3487A LOT# J0108145V| EXTENSION MODEL 7495-25 LOT# NAF021286N| EXPLANTED| PROGRAMMER MODEL 7434 LOT# YN0047880P