BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3022415 · Received March 22, 2013

    Report

    Report Number
    1627487-2013-06086
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 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

    (B)(4): 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 2. REFERENCE MFR REPORT: 1627487-2013-06087. THE PT HAS TWO IPGS IMPLANTED. IT WAS REPORTED ONE OF THE PT'S IPG WAS REVISED DUE TO DISCOMFORT. THE PT HAD GAINED WEIGHT AND SHE WAS EXPERIENCING SOME DISCOMFORT AT THE IPG SITE. AFTER THE SURGERY THE PT STATED THE NEW IPG LOCATION FELT MUCH BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119539 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2887050

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention SCS EXTENSION: MODEL 3383(X2)| IMPLANT:| SCS LEAD: MODEL 3214| SCS LEAD: MODEL 3286(X2)| SCS ANCHOR: MODEL 1192(X2)| IMPLANT:| IMPLANT:| IMPLANT: