BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD

    MDR report key: 2143103 · Received June 23, 2011

    Report

    Report Number
    1627487-2011-03126
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 25, 2011
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT 1627487-2011-03127. THE PATIENT RECEIVED A SCS SYSTEM INCLUDING TWO PERCUTANEOUS LEADS (FROM 2 DIFFERENT LOTS) ON (B)(6) 2011 FOR LOW BACK AND LEG PAIN. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF NUMBNESS OF HER LEGS ON (B)(6) 2011. THE PATIENT ALLEGEDLY CONTINUED TO FEEL NUMBNESS AND WEAKNESS IN HER LEGS; THEREFORE, THE PHYSICIAN DECIDED TO EXPLANT THE SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT STILL FELT THE NUMBNESS AND WEAKNESS POSTOPERATIVE. FOLLOW UP ON THE PATIENT FOUND THAT THE DOCTOR HAD PERFORMED A CT SCAN AND MRI ON THE PATIENT AND FOUND NO ANOMALIES. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3170804

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention IMPLANTED:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1194| IMPLANTED: