BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD, 60 CM

    MDR report key: 2251213 · Received September 12, 2011

    Report

    Report Number
    1627487-2011-01925
    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

    MANUFACTURER'S EVAL: THE RETURNED PRODUCT WAS NOT ANALYZED AS THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED VIA LAB TESTING. 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 UNDERWENT A PROCEDURE TO RECEIVE A SCS TRIAL SYSTEM. IT WAS REPORTED THAT THE PHYSICIAN MADE SIX ATTEMPTS WITH A NEEDLE TO PLACE THE TRIAL LEAD; HOWEVER, THERE WAS NO ROOM FOR LEAD PLACEMENT DUE TO THE PT'S ANATOMY. IT WAS REPORTED THAT THE PT HAD SCAR TISSUE AND A FUSION FROM L4 TO T12. THE PHYSICIAN DECIDED TO ABORT THE CASE. NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3389096

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention