BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3012199 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-15344
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    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

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSIONS: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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: 1627487-2013-15345. IT WAS REPORTED THE PATIENT HAS A CYST-LIKE MASS THAT IS RED AND SWOLLEN BETWEEN HIS MID BACK AND IPG SITE INCISIONS. THE PHYSICIAN PRESCRIBED THE PATIENT 14 DAYS OF ANTIBIOTICS. A CULTURE WAS NOT PERFORMED. ADDITIONALLY, THE PATIENT INDICATED HE IS NOT EXPERIENCING RELIEF WITH HIS SCS SYSTEM. THE PATIENT STATED HE IS UNHAPPY WITH THE PARASTHESIA COVERAGE OF HIS PHANTOM LIMB PAIN AND WANTS HIS SCS SYSTEM REMOVED. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE CONCERNING THE INADEQUATE PAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106204 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3741500

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention SCS ANCHOR: MODEL 1192| IMPLANT DATE:| SCS ANCHOR: MODEL 1194| IMPLANT DATE: