BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2980082 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-04230
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R,
    Adverse Event
    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 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: 1627487-2013-04231. THE PT REC'D TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT HAD FALLEN ON THE IPG POCKET SITE, AND THE AREA WAS BRUISED. THE PT SUBSEQUENTLY WAS RECEIVING AN UNCOMFORTABLE SHOOTING PAIN AROUND THE MIDDLE OF HER BACK WHEN THE STIMULATION WAS TURNED ON. IT WAS REPORTED AN X-RAY DID NOT REVEAL ANY ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77233 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3157572

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: