BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3192099 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-02858
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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: 1627487-2013-02859. THE PATIENT HAS TWO LEADS FROM THE SAME LOT. IT WAS REPORTED, THE PATIENT COMPLAINED OF SHOCKING AND PAIN AT HER IPG SITE. THE PATIENT STATED, SHE HAS THE SYSTEM TURNED OFF, BUT SHE OCCASIONALLY EXPERIENCES INTENSE SHOCKS AT THE SITE. SHE REPORTED, THE SHOCKING CAUSES PAIN THAT RADIATES FROM HER BUTTOCKS TO HER BACK. IT WAS REPORTED A CT SCAN OF THE SYSTEM SHOWED NO ANOMALIES, AND REPROGRAMMING EFFORTS HAD BEEN UNSUCCESSFUL AT RESOLVING THE ISSUE. THE PATIENT ALSO REPORTED THE SYSTEM DOES NOT HELP HER AND SHE HAD NOT USED IT IN A WHILE. SURGICAL INTERVENTION WILL LIKELY BE UNDERTAKEN AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280566 EON MINI SCS IPG LGW ST. JUDE MEDICAL NEUROMODULATION 3788 2926147

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other IMPLANT DATE:| SCS EXTENSION: MODEL 3382 (2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)