BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2133605 · Received June 16, 2011

    Report

    Report Number
    1627487-2011-01671
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    THE PT REC'D HER SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT WAS IN A CAR ACCIDENT, AND SUBSEQUENTLY SHE FELT STIMULATION LOWER THAN USUAL. SHE STATED THAT SHE NORMALLY FEELS STIMULATION IN HER LOW BACK AND BUTTOCK REGION, BUT SHE IS NOW FEELING IT MORE IN HER LEGS. THE PT WILL DISCUSS THE ISSUE WITH HER PHYSICIAN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL- NEUROMODULATION 3186 3203885

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention SCS IPG, MODEL: 3788| IMPLANTED:| SCS ANCHOR, MODEL: 1192 X 2| IMPLANTED: