BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2886701 · Received December 18, 2012

    Report

    Report Number
    1627487-2012-11853
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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 HAD PAIN AT THE IPG SITE AND THE AREA WAS RED. THE PHYSICIAN OBSERVED THE SITE AND IT WAS REPORTED THE IPG MAY BE RUBBING AGAINST THE ILIAC CREST WHEN THE PT IS IN THE SITTING POSITION. IT WAS REPORTED THE PT DID NOT WANT TO PURSUE SURGICAL INTERVENTION, SO THE PHYSICIAN WAS TO MONITOR THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3637224

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3219