BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2792064 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-11487
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    March 19, 2011
    Report Date
    September 19, 2012
    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 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

    THE PT REPORTED A HARD HIT TO HIS IPG SITE 1.5 YEARS AGO. THE PT REPORTED HE HAS HAD PAIN AT THE IPG SITE SINCE THE INCIDENT. IT WAS REPORTED SURGICAL INTERVENTION MAY BE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3165987

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)