BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3962475 · Received July 14, 2014

    Report

    Report Number
    1627487-2014-00424
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ST. JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 3 OF 3. REFERENCE MFR REPORT #S 1627487-2014-00422 AND 1627487-2014-00423. IT WAS REPORTED THE PATIENT ((B)(6)) IS EXPERIENCING INTERMITTENT OVERESTIMATION FROM HER THERAPY SYSTEM. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR TWO LEAD CONTACTS. THE PATIENT REPORTEDLY HAS SUFFERED FALLS RECENTLY. X-RAYS WILL BE TAKEN FOR FURTHER INTERROGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410187 EON SCS IPG GZB ST. JUDE MED - NEUROMODULATION 3716 117174

    Patients

    Seq Age Sex Outcome Treatment
    1 Other