BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 1980342 · Received February 2, 2011

    Report

    Report Number
    1627487-2011-00115
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 REC'D HER SCS SYSTEM ON (B)(6) 2010, CONSISTING OF AN IPG AND SURGICAL LEAD FOR BILATERAL LEGS TO FEET AND HIP PAIN. IT WAS REPORTED THAT SHE IS EXPERIENCING A PAINFUL SENSATION IN HER HIPS AND LEGS. THE REPORTED DISCOMFORT IS SAID TO BEGIN APPROX 15 MINS AFTER HER STIMULATION IS INITIATED. THE PT HAS REPORTEDLY UNDERGONE SEVERAL REPROGRAMMING SESSIONS IN EFFORTS TO ALLEVIATE THE ALLEGED PAIN. IT WAS REPORTED THAT THE PT WAS RECENTLY GIVEN SEVERAL NEW CYCLE PROGRAMS TO UTILIZE. F/U ON THIS MATTER FOUND THAT THERE HAS BEEN NO SIGNIFICANT IMPROVEMENT REGARDING THE PT'S REPORTED DISCOMFORT. HER SITUATION WILL CONTINUED TO BE MONITORED WITH THE USE OF THE NEWLY ISSUED PROGRAMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 3131343

    Patients

    Seq Age Sex Outcome Treatment
    1