BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2620435 · Received June 12, 2012

    Report

    Report Number
    1627487-2012-09776
    Event Type
    Injury
    Date Received
    June 12, 2012
    Date of Event
    May 15, 2012
    Report Date
    May 22, 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

    DEVICE REPORT 1 OF 2: REFERENCE MFR REPORT: 1627487-2012-09777. THE PATIENT IS IMPLANTED WITH TWO PERCUTANEOUS LEADS (FROM DIFFERENT LOTS). IT WAS REPORTED THE PATIENT HAD BEEN EXPERIENCING PERSISTENT POSITIONAL HEADACHES SINCE IMPLANT PRESUMABLY FROM CEREBROSPINAL FLUID LEAK. THE PATIENT WAS ADVISED TO THOROUGHLY REST. FURTHER FOLLOW-UP INDICATED THAT HEADACHE SYMPTOMS HAVE RESOLVED. THE PATIENT WAS PROGRAMMED AND REPORTED EFFECTIVE COVERAGE IN THE DESIRED PAIN PATTERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3382913

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SCS ANCHOR: MODEL 1192X2| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788