BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 2915337 · Received December 28, 2012

    Report

    Report Number
    1627487-2012-16028
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 1, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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

    DEVICE 2 OF 4. REFERENCE MFR REPORT#: 1627487-2012-16027, 16029, 16030. THE PT HAS FOUR LEADS FOR OFF-LABEL USE. IT WAS REPORTED THE PT IS NO LONGER RECEIVING ADEQUATE COVERAGE DUE TO LOSING A SIGNIFICANT AMOUNT OF WEIGHT. REPROGRAMMING WAS UNSUCCESSFUL. THE PT WILL UNDERGO SURGICAL INTERVENTION ON A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3399964

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SCS IPG: MODEL 3716| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3343