BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG

    MDR report key: 2121014 · Received June 9, 2011

    Report

    Report Number
    1627487-2011-02813
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    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

    THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2011, IT WAS REPORTED THAT THE PATIENT HAD FELL ON HER IPG SITE IN (B)(6) AND SINCE THEN, WHENEVER SHE TURNS THE STIMULATION ON OR OFF, SHE FEELS A STINGING SENSATION AT THE IPG SITE. SHE RECEIVED GOOD STIMULATION OTHERWISE. AN X-RAY SHOWED NO ANOMALIES. THERE ARE NO IMMEDIATE PLANS FOR SURGICAL INTERVENTION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3203834

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANT:| SCS LEADS: MODEL UNK