BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2892846 · Received December 28, 2012

    Report

    Report Number
    1627487-2012-15126
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED, THE PT'S SCS SYSTEM HAS NOT WORKED FOR APPROXIMATELY FOUR TO FIVE YRS. IT WAS REPORTED, THE LAST TIME THE PT TRIED TO CHARGE, THE CHARGER WAS NOT ABLE TO LOCATE THE IPG. THE SJM REP MET WITH THE PT AND CONFIRMED THE IPG WILL NO LONGER COMMUNICATE WITH EXTERNAL DEVICES. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 67112

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention IMPLANT DATE:| SCS EXTENSION: MODEL 3343| IMPLANT DATE:| SCS LEAD: MODEL 3255 (2)