BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBRA CONVENTIONAL IPG

    MDR report key: 2080485 · Received April 22, 2011

    Report

    Report Number
    1627487-2011-01409
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THIS MODEL IS NOT APPROVED FOR USE IN THE UNITED STATES AND WAS USED AS PART OF A CLINICAL STUDY. THE CLINICAL STUDY WAS NOT SPONSORED OR MONITORED BY THE MANUFACTURER. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED AN UNAPPROVED DBS (DEEP BRAIN STIMULATION) SYSTEM, INCLUDING AN IPG, AS PART OF AN INVESTIGATOR INITIATED CLINICAL STUDY. IT WAS REPORTED THAT THE IPG DISPLAYED A LOW BATTERY WARNING MESSAGE. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE IPG IN (B)(6) 2011. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBRA CONVENTIONAL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 6644 175562

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention