BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2871484 · Received December 5, 2012

    Report

    Report Number
    1627487-2012-12723
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 14, 2012
    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

    IT WAS REPORTED THE PATIENT BENT OVER AND FELT A SNAP AT THE LEAD INCISION SITE. IT WAS ALSO REPORTED THE PATIENT HAS PAIN NEAR THE LEAD IMPLANT SITE. X-RAYS SHOWED NO SIGNIFICANT MIGRATION. IT WAS REPORTED THE PATIENT WILL MEET WITH THE PHYSICIAN TO DETERMINE NEXT STEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3759082

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention SCS ANCHOR, MODEL 1192| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788