BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110834 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-02605
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. EVALUATION: 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. CONCLUSION: 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 3. REFERENCE MFR. REPORTS: 1627487-2013-02606 AND 1627487-2013-02607. THE PT HAD FOUR LEADS FROM 2 SEPARATE LOTS. IT WAS REPORTED, THE PT'S IPG HAD ERODED THROUGH THE SKIN AND THE PT COMPLAINED OF INEFFECTIVE STIMULATION COVERAGE. CONSEQUENTLY, THE PT'S SYSTEM WAS REMOVED DUE TO THE ISSUES. THE PT'S WIFE COULD NOT RECALL THE EXPLANT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204854 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2779845

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention SCS EXTENSION: MODEL 3341| IMPLANT DATE:| SCS EXTENSION: MODEL 3342| IMPLANT DATE: