BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2041106 · Received March 29, 2011

    Report

    Report Number
    1627487-2011-00425
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 AN SCS SYSTEM INCLUDING A PERCUTANEOUS LEAD ON (B)(6) 2010. IT WAS REPORTED THAT SHE WAS WITHOUT STIMULATION. AN X-RAY REVEALED THAT THE PT LEAD HAS FRACTURED. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO RECTIFY THIS MATTER; HOWEVER, A DATE FOR THE PROCEDURE HAS NOT BEEN SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3186 3088707

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention SCS IPG: MODEL 3788,| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD ANCHOR: MODEL 1192,