BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBRA

    MDR report key: 2862090 · Received November 29, 2012

    Report

    Report Number
    1627487-2012-00782
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 INFORMATION 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

    IT WAS REPORTED THE PT ((B)(6)) EXPERIENCED UNINTENDED STIMULATION IN HIS HEAD DURING A FOLLOW-UP CLINICAL APPOINTMENT. THE REPORTED SENSATION IS DESCRIBED AS A DISTURBING TINGLE AND IS SAID TO OCCUR WHEN COMMUNICATION IS EITHER INITIATED OR TERMINATED BETWEEN THE IPG AND THE PT AND CLINICIAN PROGRAMMERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBRA DBS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 6644 3463360

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DBS POCKET ADAPTER: MODEL 2304| IMPLANT DATE: