BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 2120959 · Received June 9, 2011

    Report

    Report Number
    1627487-2011-02800
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2010. ON (B)(6) 2011, IT WAS REPORTED THAT THE IPG IS LOOSE IN THE POCKET AND MOVES AROUND A LOT. IT IS NOT CAUSING PAIN AND THE PATIENT HAS STIMULATION. THERE ARE NO IMMEDIATE PLANS FOR SURGICAL INTERVENTION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3170802

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANT:| IMPLANT:| OCTRODE LEAD: MODEL 3186| OCTRODE LEAD: MODEL 3186