BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2153386 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-01697
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    May 7, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 A SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2011 FOR LEFT LEG PAIN. IT WAS REPORTED THAT THE PT FELT STIMULATION IN THE ABDOMEN, HIP AND GROIN, AND NO LONGER TO THE INTENDED AREA. AN X-RAY REVEALED THE LEAD HAD MIGRATED. THE PHYSICIAN PLANS TO PERFORM A LEAD REVISION PROCEDURE; HOWEVER, THE SURGERY DATE IS CURRENTLY UNDETERMINED. NO FURTHER INFO 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 3126663

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention