BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2982769 · Received February 15, 2013

    Report

    Report Number
    1627487-2013-01163
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 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 INFO 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 PATIENT IS EXPERIENCING WEAKNESS IN HIS RIGHT LEG SINCE HAVING HIS SCS SYSTEM IMPLANTED. A MYELOGRAM WAS NEGATIVE FOR CORD COMPRESSION. AN EMG WAS ORDERED. FOLLOW UP INFO IDENTIFIED THE PATIENT IS GAINING STRENGTH BACK IN HIS LEG AND IS GOING TO PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69363 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3835941

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788