BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110924 · Received May 8, 2013

    Report

    Report Number
    1627487-2013-13709
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R 1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 2 OF 2. REFERENCE MFR. REPORT: 1627487-2013-13708. THE PT REPORTED SHE HAS NOT USED HER SCS SYSTEM IN OVER 2 YEARS. THE PT STATED THE SYS WAS NOT ADDRESSING HER PAIN EVEN AFTER MULTIPLE ATTEMPTS OF REPROGRAMMING. THE PT ALSO REPORTED SHE IS CURRENTLY EXPERIENCING PAIN AT HER IPG SITE. THE PT WOULD LIKE HER SCS SYS EXPLANTED. IT WAS NOTED THE PT IS TENTATIVELY SCHEDULED TO MEET WITH HER PHYSICIAN AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200163 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2847286

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANT: