BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4091915 · Received August 28, 2014

    Report

    Report Number
    1627487-2014-23563
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    IT WAS REPORTED THE PATIENT WAS WITHOUT STIMULATION. DIAGNOSTIC TESTING REVEALED INVALID IMPEDANCE READINGS. SUBSEQUENTLY, THE PATIENT UNDERWENT SURGICAL INTERVENTION, WHERE HIS IPG WAS REMOVED AND REPLACED. HOWEVER, THE INVALID IMPEDANCE ISSUE REMAINS UNRESOLVED. SUBSEQUENTLY, AN SJM REPRESENTATIVE WAS ABLE TO RESTORE STIMULATION WITH POST-OPERATIVE PROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526170 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 2868076

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other SCS LEAD: MODEL 3189 (2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE: