BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2926060 · Received January 17, 2013

    Report

    Report Number
    1627487-2013-13099
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 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 WAS FEELING STIMULATION, HOWEVER, THE PT WAS UNABLE TO COMMUNICATE WITH OR CHARGE HIS IPG. IT WAS ALSO REPORTED THE PT HAD A RECENT FALL. A NEW CHARGER WAS SENT TO THE PT. F/U INFO IDENTIFIED THE NEW CHARGER WAS ALSO UNABLE TO LOCATE THE PT'S IPG. X-RAYS IDENTIFIED THE PT'S IPG HAD FLIPPED. THE PT UNDERWENT A SURGICAL PROCEDURE TO ADDRESS THE ISSUE. THE PHYSICIAN FLIPPED THE IPG BACK INTO THE CORRECT POSITION. IT WAS REPORTED THE PT WAS DOING WELL POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26042 EON SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3716 3731667

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3228