BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 3110936 · Received May 8, 2013

    Report

    Report Number
    1627487-2013-03617
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    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

    EVAL: METHOD ¿ THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS- THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-03618. IT WAS REPORTED, THE PATIENT HAS AN INFECTION AT HIS INCISION SITES. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE HIS INCISION SITES WERE CLEANED AND HIS SCS IPG WAS EXPLANTED ON (B)(6) 2013. IT WAS ALSO REPORTED, THE PATIENT RECEIVED INTRAVENOUS ANTIBIOTICS, WILL HAVE ANOTHER INCISION CLEANING AND IS BEING MONITORED. ADDITIONALLY, THE SITES HAVE BEEN CULTURED. FOLLOW-UP IDENTIFIED THE PATIENT¿S SCS LEAD WAS EXPLANTED ON (B)(6) 2013, THE PATIENT IS RECEIVING ORAL ANTIBIOTICS, AND THE INFECTION IS CLEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200233 EONC SCS IPG LGW ST. JUDE MEDICAL- NEUROMODULATION 3688 3915180

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R