BEUDAMED
    FDA Adverse Event Death Summary report: N

    EON

    MDR report key: 2895171 · Received December 20, 2012

    Report

    Report Number
    1627487-2012-02883
    Event Type
    Death
    Date Received
    December 20, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    IT WAS REPORTED THE PT UNDERWENT SURGERY RELATED TO HIS LUNGS AND HAD EXPERIENCED A PERSISTENT FEVER SINCE THE LUNG SURGERY. THE SURGEON INVOLVED WITH THE LUNG SURGERY ATTRIBUTED THE PERSISTENT FEVER TO THE PT'S SCS SYSTEM. THE PT'S WIFE STATED THE PT HAS HAD INTERMITTENT, UNEXPLAINED FEVERS SINCE IMPLANT. THE PT WAS ADVISED TO SEE HIS IMPLANTING PHYSICIAN CONCERNING THE ISSUE. FOLLOW-UP IDENTIFIED THE PT DIED ON (B)(6) 2012. THE CAUSE OF DEATH IS CURRENTLY UNK. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3416838

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R SCS LEAD: MODEL 3186 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)