BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2921817 · Received January 14, 2013

    Report

    Report Number
    1627487-2013-04064
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 25, 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

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 WAS ADMITTED TO THE HOSP DUE TO SUSPICION OF INFECTION AT THE IPG SITE. THE PT HAD DISCOLORATION AND SWELLING AT THE IPG SITE. IT WAS REPORTED A BLOOD TEST INDICATED INFECTION. THE PT WAS PLACED ON IV ANTIBIOTICS. F/U IDENTIFIED THE IMPLANTING PHYSICIAN FELT THE ISSUE WAS A BURST BLOOD VESSEL, AND NOT AN INFECTION. THE PT FINISHED THE ANTIBIOTIC REGIMEN, AND WAS RELEASED FROM THE HOSP. FURTHER F/U FOUND THAT THE PT HAD HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21048 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3733423

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R SCS LEAD: MODEL 3228| IMPLANT DATE: