BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2980003 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-01204
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    November 14, 2012
    Report Date
    January 29, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 EXPERIENCES A SHOCKING SENSATION AND THEN HER STIMULATION TURNS OFF BY ITSELF. SHE ALSO HAS TO CHARGE MORE FREQUENTLY THAN BEFORE. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND LEAD DIAGNOSTICS SHOWED LOW IMPEDANCES. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77695 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3734287

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186| SCS ANCHOR: MODEL 1192 (2)