BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2973596 · Received February 19, 2013

    Report

    Report Number
    1627487-2013-02251
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    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 FIELD ADVISORIES. 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 3 OF 3. REFERENCE MFR REPORTS: 1627487-2013-02249 AND 1627487-2013-02250. THE PATIENT RECEIVED THREE LEADS (FROM TWO SEPARATE LOTS) AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PATIENT EXPERIENCED A FALL WITHIN THE LAST TWO WEEKS AND SUBSEQUENTLY SHE STARTED FEELING A SHOCKING SENSATION WHEN SHE TURNED STIMULATION ON. REPROGRAMMING WAS UNABLE TO PROVIDE THE PATIENT WITH EFFECTIVE STIMULATION OR RESOLVE THE ISSUE. IT WAS REPORTED SURGICAL INTERVENTION WILL BE UNDERTAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72523 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3185654

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION, MODEL 3341| SCS ANCHOR, MODEL 1192 (3)