BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 3192054 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-15828
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 29, 2013
    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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT IS EXPERIENCING INEFFECTIVE STIMULATION AS WELL AS FEELING "ODD" SENSATIONS IN HER LEFT LOWER ARM AND HAND. THE PT DENIES ANY FALLS AND THAT HER HAND APPEARS PUFFY WHEN SHE WAKES UP. THE PT WAS ADVISED TO CONSULT WITH HER PHYSICIAN REGARDING THE PUFFINESS. X-RAYS AND NERVE TESTING ARE TO BE PERFORMED AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281633 EXCLAIM 8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3225 3539968

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other IMPLANT DATE:| SCS IPG, MODEL 3788