BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 2894863 · Received December 20, 2012

    Report

    Report Number
    1627487-2012-02856
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    March 22, 2012
    Report Date
    March 22, 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 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 EXPERIENCED A FALL AND SUBSEQUENTLY HIS STIMULATION SHIFTED FROM HIS GROIN AREA TO HIS LEG. IT WAS REPORTED THE PT STILL HAD SOME STIMULATION IN HIS GROIN, BUT IT WAS UNCOMFORTABLE. X-RAYS DID NOT REVEAL ANY LEAD MIGRATION. THE PHYSICIAN DECIDED TO REMOVE THE LEAD AND WILL CONDUCT A PNS TRIAL IN THE FUTURE. IT WAS REPORTED THE PT'S IPG REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCLAIM 8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3224 3383480

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788