BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2821160 · Received October 25, 2012

    Report

    Report Number
    1627487-2012-02579
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 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
    TX, 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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-02580. IT WAS REPORTED THE PT FELT A BURNING SENSATION AT THE IPG SITE WHILE CHARGING. SHE REPORTED SHE ONLY NEEDED TO CHARGE ABOUT 15 MINS AND THE WARMTH WAS TOLERABLE. IT WAS REPORTED THE IPG SITE DID NOT APPEAR RED OR IRRITATED. THE SJM REP ADVISED THE PT OF CHARGING PRECAUTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3783285

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192| IMPLANT DATE:| SCS LEAD: MODEL 3186