BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2023250 · Received February 15, 2011

    Report

    Report Number
    1627487-2011-01243
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 29, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS (FROM THE SAME LOT), ON (B)(6) 2009. IT WAS REPORTED THAT THE PT FELL ON ICE AND CONSEQUENTLY HIS STIMULATION CHANGED. ALTHOUGH AN X-RAY DID NOT SHOW LEAD MIGRATION, THE PT REPORTED THAT HE FELT STIMULATION LOWER AFTER THE FALL. HE ALLEGEDLY REQUIRED A GREATER AMPLITUDE FOR HIS STIMULATION SETTINGS AS WELL. F/U ON THE PT FOUND THAT HE WAS REPROGRAMMED AND WAS PRESCRIBED ADD'L MEDICATION TO HELP HIS PAIN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION DIV. 3181 171866

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention