BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBRA

    MDR report key: 3193609 · Received June 25, 2013

    Report

    Report Number
    1627487-2013-10210
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT APPROVED FOR SALE IN THE USA, BUT IS SIMILAR TO A USA MARKETED/APPROVED DEVICE. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 4. REFERENCE MFR REPORT: 1627487-2013-10211, 10213. THE PT (B)(6) RECEIVED A DBS SYSTEM WHICH INCLUDED THE IPG, LEAD AND TWO LEAD EXTENSIONS (FROM DIFFERENT LOTS). IT WAS REPORTED THE PT'S LEAD PULLED OUT OF THE LEAD EXTENSION. IN ADDITION, IT WAS NOTED THAT THERE WAS A BAD CONNECTION AT THE IPG WHICH RESULTED IN FLUID ENTERING THE IPG HEADER. THE PHYSICIAN ELECTED TO REPLACE THE IPG. HIGH IMPEDANCES WERE IDENTIFIED POST-OPERATIVELY; HOWEVER, REPROGRAMMING PROVIDED EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287447 LIBRA DBS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 6644 3779829

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other