BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2980238 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-02278
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A 1627487-05242011-002-R AND 1627487-12192011-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORIES AND A FIELD CORRECTION. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2013-02279. IT WAS REPORTED THE PT EXPERIENCES PERSISTENT DISCOMFORT AT HER IPG SITE EVEN WHEN STIMULATION IS OFF. THE PT ALSO REPORTED SHE HAS HEATING AT THE POCKET SITE DURING CHARGING. SHE STATED SHE FEELS HER IPG SITE GETS HOT EVERY TIME SHE CHARGES AND THE SENSATION HAS PROGRESSED. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT. NO FURTHER INO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78852 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2898581

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention SCS EXTENSION: MODEL 3383 (2)| SCS LEAD: MODEL 3228| IMPLANT DATE:| IMPLANT DATE: