BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2791990 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-01851
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-01852. IT WAS REPORTED THE PATIENT IS EXPERIENCING PAIN AND PRESSURE ON HER RIGHT SIDE AT THE IPG SITE WHEN SHE STANDS UP AND WALKS AND MUSCLE SPASMS IN HER LOWER BACK. SHE ALSO REPORTED EXPERIENCING A WARM SENSATION AT HER IPG SITE. FOLLOW UP INFORMATION IDENTIFIED SHE CONTINUES TO HAVE THE PAIN AT THE IPG IMPLANT SITE AND HER LOWER BACK CONTINUES TO CAUSE HER DISCOMFORT. SHE IS NO LONGER EXPERIENCING WARMTH AT THE IPG SITE. THE PATIENT WAS SEEN BY HER PAIN MANAGEMENT PHYSICIAN AND HE ADVISED HER TO WAIT 4 WEEKS BEFORE ADDRESSING IT. FOLLOW UP IS PENDING WITH HER PHYSICIAN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3744704

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SCS ANCHOR: MODEL 1194(2)| IMPLANT: