BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3022401 · Received March 22, 2013

    Report

    Report Number
    1627487-2013-06090
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R 1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBERS: 1627487-12192011-003-R, 1627487-05242011-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION AND 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 3. REFERENCE MFR REPORT: 1627487-2013-06091, REFERENCE MFR REPORT: 1627487-2013-06092. THE PT HAS THREE IPGS. IT WAS REPORTED THE IPG FOR LEFT INGUINAL HERNIA IS NOT COMMUNICATING WITH THE PROGRAMMER OR THE CHARGER AND THE PT DOES NOT HAVE STIMULATION. THE PT HAS SCHEDULED AN APPOINTMENT WITH HIS PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION. F/U IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120984 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2749510

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR IMPLANT:| IMPLANT:| SCS LEAD: MODEL 3186 (X2)| SCS EXTENSION: MODEL 3341| IMPLANT:| SCS ANCHOR: MODEL 1194| IMPLANT:| SCS ANCHOR: MODEL 1192 (X3)| IMPLANT:| SCS LEAD: MODEL 3181 (X3)| IMPLANT:| SCS LEAD: MODEL 3183| IMPLANT:| SCS LEAD: MODEL 3186| SCS LEAD: MODEL 3186 (X3)| IMPLANT: