BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2010931 · Received March 4, 2011

    Report

    Report Number
    1627487-2011-02273
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    October 14, 2010
    Report Date
    February 11, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2011-02272. THE PT ((B)(6)) RECEIVED HER SCS SYS, INCLUDING A PERCUTANEOUS LEAD AND AN IPG, ON (B)(6) 2009. IT WAS REPORTED THE SCS SYS WAS EXPLANTED AND NOT REPLACED DUE TO PAIN AT THE IMPLANT SITE. NEITHER THE EXPLANTED IPG NOR THE EXPLANTED LEAD HAVE BEEN RETURNED TO THE MFR FOR ANALYSIS. F/U FOUND THE PT IS WORKING CLOSELY WITH HER PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION. IT HAS NOT YET BEEN DETERMINED WHETHER OR NOT THE PT WILL RECEIVE A REPLACEMENT SCS SYS.

    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 173197

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention