BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3032265 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-01357
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-1356. THE PT HAS TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT SUFFERED A FALL AND LOST STIMULATION. X-RAYS WERE TAKEN AND SHOWED THE LEAD WAS PARTIALLY OUT OF THE IPG HEADER. THE PT UNDERWENT REVISION SURGERY ON (B)(6) 2013 WHERE THE LEAD WAS RE-INSERTED INTO THE IPG. THE PT IS NOW RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131186 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3875424

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)