BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2153363 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-01691
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 2, 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
    UK
    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 1 OF 2. REFERENCE MFR REPORT: 1627487-2011-01698. IT WAS REPORTED THAT THE PT (B)(6) EXPERIENCED AN UNCOMFORTABLE SENSATION IN HER BACK. THE PHYSICIAN TOOK THE PT INTO SURGERY AND PERFORMED INTRAOPERATIVE TESTING. IT WAS REPORTED THAT THE LEAD WAS DAMAGED AND THE ANCHOR WAS BROKEN. THE PHYSICIAN EXPLANTED THE LEAD AND ANCHOR AND REPLACED THE LEAD ON (B)(6) 2011. THE PT REPORTED EFFECTIVE STIMULATION POSTOPERATIVE, AND NO FURTHER PT ISSUES WERE 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 3186 2790278

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention