BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2792219 · Received October 10, 2012

    Report

    Report Number
    1627487-2012-11456
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 17, 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 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

    IT WAS REPORTED THE PT WAS UNABLE TO COMMUNICATE WITH THE IPG USING THE PROGRAMMER, AND COULD NOT TURN THE STIMULATION OFF. FOLLOW UP IDENTIFIED THE PHYSICIAN REQUESTED X-RAYS WHICH REVEALED THE IPG HAD FLIPPED OVER INSIDE THE POCKET. THE PT WAS REFERRED TO A SURGEON WHO FLIPPED THE IPG BACK OVER MANUALLY. IT WAS REPORTED COMMUNICATION WAS REESTABLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3612445

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3219