BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2677063 · Received July 27, 2012

    Report

    Report Number
    1627487-2012-01329
    Event Type
    Injury
    Date Received
    July 27, 2012
    Date of Event
    May 24, 2012
    Report Date
    May 24, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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 PT IS EXPERIENCING PERSISTENT PAIN AT HER IPG SITE THAT RADIATES DOWN HIS RIGHT LEG. THE PT MET WITH HIS PHYSICIAN AND FLUOROSCOPY SHOWED THE IPG WAS POSITIONED ON THE ILIAC CREST OF THE RIGHT HIP. IT WAS ALSO REPORTED, THE PT EXPERIENCES INTERMITTENT STIMULATION. AN SJM REP HAS MET WITH THE PT AND REPROGRAMMED HIS IPG MULTIPLE TIMES, BUT WITHIN A FEW DAYS STIMULATION IS OFF AGAIN. THE PT IS SCHEDULED FOR SURGERY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL RECHARGEABLE IPG SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3586533

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANT DATE: