BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 2092583 · Received May 3, 2011

    Report

    Report Number
    1627487-2011-02525
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 PT RECEIVED AN SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2010. THE PT PRESENTED TO THE EMERGENCY ROOM (ER) REPORTING A SHOCKING SENSATION IN HER LEG; HOWEVER, THE PT HAD DISABLE THE SCS STIMULATION THREE OR FOUR DAYS PRIOR. THE SENSATION ONSET WAS APPROX TWO HOURS PRIOR TO THE PT'S ER ADMISSION. LATER, THE PT WAS ABLE TO MEET WITH HER IMPLANTING PHYSICIAN FOR TESTING OF THE SCS SYSTEM. THE PHYSICIAN DETERMINED THE PT'S PAIN WAS NOT DEVICE-RELATED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3161616

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention