BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3031948 · Received March 28, 2013

    Report

    Report Number
    1627487-2013-13455
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 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 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. REF MFR REPORT: 1627487-2013-13456. IT WAS REPORTED THE PT UNDERWENT A SURGICAL PROCEDURE AND HAD HER IPG REPOSITIONED. THE PT'S IPG WAS ORIGINALLY LOCATED AT HER BELTLINE, WHICH THE PT DID NOT CARE FOR. IT WAS ALSO NOTED DURING THE PROCEDURE, THE PHYSICIAN OPTED TO EXPLANT AND REPLACE THE PT'S LEAD. THE PT'S ORIGINAL LEAD LOCATION WAS PROVIDING RIGHT SIDED STIMULATION COVERAGE; HOWEVER, THE PT'S PAIN WAS MOSTLY ON HER LEFT SIDE. THE PT WAS SATISFIED WITH HER NEW IPG LOCATION POSTOPERATIVE. IT WAS NOTED THE PT'S STIMULATION HAD NOT BEEN TURNED ON YET. FOLLOW-UP PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128036 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3762471

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention SCS ANCHOR, MODEL 1194 (2)| IMPLANT DATE: