BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD, 60CM LENGTH

    MDR report key: 2212610 · Received August 11, 2011

    Report

    Report Number
    1627487-2011-06054
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    THE PT (B)(6) RECEIVED AN SCS SYSTEM INCLUDING A PERCUTANEOUS LEAD ON (B)(6) 2011 FOR PAIN IN THE RIGHT QUAD AREA. IT WAS REPORTED THAT THE PT IS FEELING STIMULATION IN HER RIGHT HIP. FURTHER INTERROGATION REVEALED THAT THE PT'S LEAD HAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO REPOSITION AND RE-SECURE THE LEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3224742

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANT:| SCS IPG: MODEL UNK