BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3031930 · Received March 28, 2013

    Report

    Report Number
    1627487-2013-00192
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DEVICE 2 OF 2. REF MFR REPORT #: 1627487-2013-00191. IT WAS REPORTED, THE PT ((B)(6)) IS WITHOUT STIMULATION. A DIAGNOSTIC TEST REVEALED IMPEDANCE ISSUES FOR ALL LEAD CONTACTS. PRIOR TO THIS OCCURRENCE, THE PT REPORTEDLY SUFFERED A FALL IMPACTING THE IPG SITE. THE DECISION REGARDING THE NEXT COURSE OF ACTION IN THIS MATTER IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128009 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 2872643

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention