BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2800831 · Received October 18, 2012

    Report

    Report Number
    1627487-2012-02522
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    May 1, 2012
    Report Date
    September 24, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R,
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORIES. 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 HAS FELT AN INTERMITTENT HEATING SENSATION AT THE IPG SITE THAT CAUSES DISCOMFORT AT TIMES. SHE STATED, THE HEATING IS NOT RELATED TO CHARGING AND SHE USES HER STIMULATION CONSTANTLY. THE PT DENIED ANY TRAUMA TO THE SITE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2834058

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention SCS LEAD: MODEL: 3189 (2)| IMPLANT DATE:| SCS ANCHOR: MODEL: 1194 (2)| IMPLANT DATE: