BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2051305 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-01347
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT ((B)(6)) RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2011. IT WAS REPORTED THAT THE PT COMPLAINED OF A BURNING PAIN AT THE IPG POCKET SITE WHEN STIMULATION IS ON. SHE STATED THAT THE PAIN IS AT ITS PEAK AFTER APPROXIMATELY TWO HOURS OF STIMULATION. DUE TO THE PAIN, THE PT REPORTED THAT SHE HAD TO TURN OFF THE IPG AND SUBSEQUENTLY THE PAIN SUBSIDES. IT WAS REPORTED THAT THE DIAGNOSTIC TESTS REVEAL NORMAL IMPEDANCE READINGS, AND THE CONNECTOR BLOCK LEAD CONTACTS ARE NOT BEING USED. F/U ON THE PT FOUND THAT THE PHYSICIAN PLANS TO PERFORM AN X-RAY OF THE SYSTEM. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3788 2898581

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention