BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2861138 · Received December 4, 2012

    Report

    Report Number
    1627487-2012-15003
    Event Type
    Injury
    Date Received
    December 4, 2012
    Date of Event
    October 8, 2012
    Report Date
    November 12, 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
    IN, 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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2012-15004. IT WAS REPORTED, THE PATIENT HAD LOST STIMULATION COVERAGE IN HER LEFT LEG. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND OBSERVED HIGH AND LOW IMPEDANCES. THE SJM REPRESENTATIVE ATTEMPTED REPROGRAMMING WHICH PROVIDED COVERAGE. FOLLOW UP FOUND THE ISSUE HAD CONTINUED. IT WAS REPORTED, THE PATIENT HAD AN ULCER ON HER LEFT FOOT. THE PATIENT REPORTED THE ULCER WAS DUE TO THE LACK OF STIMULATION. X-RAYS WERE TO BE TAKEN AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2847761

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention SCS ANCHOR: MODEL 1194 (2)| IMPLANT:| SCS IPG: MODEL 3788| IMPLANT: