BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2792138 · Received October 11, 2012

    Report

    Report Number
    1627487-2012-12261
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    August 1, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-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 A FIELD ADVISORY AND IN A FIELD ACTION. 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 #1627487-2012-12262. IT WAS REPORTED THE PT HEARD A POPPING NOISE AND SENSATION AT THE IPG WHEN SHE STOOD UP. REPORTEDLY PAIN RADIATED TO HER LOWER EXTREMITIES. THE PHYSICIAN REPORTED X-RAYS OF LEAD AND IPG SHOWED NO ANOMALIES. F/U DETERMINED THE PAIN HAD SUBSIDED, BUT THE PT HAS REPORTED THE PAIN HAS RETURNED. REPORTEDLY THE PT HAS AN APPOINTMENT WITH THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3339594

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention IMPLANT DATE:| SCS EXT: MODEL 3386(2)