BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2800885 · Received October 18, 2012

    Report

    Report Number
    1627487-2012-11535
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 22, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDE DIN FIELD ADVISORIES. EVALUATION: 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. CONCLUSIONS: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFORMATION 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 HAD A STAPH INFECTION IN HIS LEG AND WAS ON ANTIBIOTICS. THE PT'S WIFE NOTED THE PT HAD A QUARTER-SIZED CIRCULAR WOUND OVER THE IPG. THE SJM REPRESENTATIVE MET WITH THE PT, AND IT WAS REPORTED THE WOUND WAS A SCAB. THE PT DID NOT HAVE FLU-LIKE SYMPTOMS. IT WAS REPORTED, THE PT HAD TURNED THE IPG OFF, AND WAS ADVISED TO LEAVE THE SYSTEM OFF UNTIL THE PHYSICIAN ADVISED A COURSE OF ACTION. THE PT REPORTED, HE HAD NOT HAD ANY HEATING WHILE RECHARGING THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3079794

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention SCS LEAD: MODEL 3183 (2)| SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE:| IMPLANT DATE: