BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2903054 · Received January 3, 2013

    Report

    Report Number
    1627487-2013-15013
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 1, 2012
    Report Date
    December 5, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    REFERENCE MFR REPORT: 1627487-2013-15014. THE PATIENT'S SCS SYSTEM INCLUDED TOW LEADS FROM DIFFERENT LOTS. IT WAS REPORTED THE PATIENT HAD NOT BEEN RECEIVING ADEQUATE STIMULATION. ADDITIONALLY, THE PATIENT REPORTED EXPERIENCING SHOCKING FROM THE SYSTEM FOLLOWING A FALL. THE PATIENT UNDERWENT REVISION SURGERY WHERE HER LEADS WERE EXPLANTED AND REPLACED. THE PATIENT REPORTED EFFECTIVE STIMULATION POSTOPERATIVE AND INDICATED THAT THE SHOCKING IS NO LONGER OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3533 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3450530

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3716