BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 4

    MDR report key: 3221763 · Received July 9, 2013

    Report

    Report Number
    1627487-2013-15923
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ST. JUDE MEDICAL, NEUROMODULATION
    Product Code
    GZB
    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 PATIENT EXPERIENCED WEAKNESS IN HER LEGS AND NUMBNESS IN HER LEGS AND STOMACH AFTER HAVING HER SCS SYSTEM IMPLANTED. THE PATIENT WENT TO THE EMERGENCY ROOM THE NEXT DAY AND A CT SCAN SHOWED AN EPIDURAL HEMATOMA. SURGICAL INTERVENTION WAS UNDERTAKEN AND BOTH THE HEMATOMA AND SCS SYSTEM WERE REMOVED. A MRI WAS TAKEN POSTOPERATIVE AND REVEALED AN ADDITIONAL HEMATOMA. THE PATIENT UNDERWENT ADDITIONAL SURGICAL INTERVENTION AND THE HEMATOMA WAS REMOVED. THE PATIENT WAS ADMITTED TO CRITICAL CARE POSTOPERATIVELY AND REGAINED FEELING AND MOBILITY IN HER LEGS, BUT STILL EXPERIENCED SOME NUMBNESS. THE PATIENT IS TO UNDERGO PHYSICAL THERAPY AND POSSIBLE REHABILITATION. THE PATIENT'S PHYSICIAN BELIEVES THE SYMPTOMS ARE DUE TO THE HEMATOMAS AND NOT THE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312407 LAMITRODE 4 SCS LEAD GZB ST. JUDE MEDICAL, NEUROMODULATION 3244 3456421

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3166 (2)| IMPLANT DATE:| SCS EXTENSION: MODEL 3341| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192 (2)