BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2251199 · Received September 12, 2011

    Report

    Report Number
    1627487-2011-04179
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 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 INFO 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

    DEVICE 2 OF 3. REFERENCE: 1627487-2011-04178, 1627487-2011-04180. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THE PT WAS EXPERIENCING PAIN AT THE IPG SITE. IN ADDITION, THE PT BELIEVED THE STIMULATION WAS CAUSING SOME MUSCLE TENSION IN HER UPPER BACK AND NECK. IT WAS REPORTED THE PT'S PHYSICIAN WANTED TO PERFORM A CT MYELOGRAM TO RULE OUT SURGICAL COMPLICATIONS FOR REPLACING THE PT'S LEADS WITH A PADDLE LEAD. IN ADDITION, THE PHYSICIAN MAY REPOSITION THE IPG. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2819722

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention IMPLANTED:| IMPLANTED:| SCS ANCHOR: MODEL 1194| SCS EXTENSION: MODEL 3382