BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110921 · Received May 8, 2013

    Report

    Report Number
    1627487-2013-13697
    Event Type
    Injury
    Date Received
    May 8, 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 1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFO 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: 1627487-2013-13698. THE PT REPORTED SHE WOULD LIKE TO HAVE HER SCS SYSTEM EXPLANTED DUE TO THE PAIN IT IS CAUSING IN HER STOMACH. THE PT STATED HER SCS SYSTEM HASN'T PROVIDED HER PROPER PAIN RELIEF SINCE IT WAS IMPLANTED. F/U INFO IDENTIFIED THE PT DID NOT WANT TO BE REPROGRAMMED AND SHE IS LOOKING FOR A NEW PHYSICIAN REGARDING A CONSULT VISIT. SURGICAL INTERVENTION MAYBE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200162 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2864606

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention