BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3082320 · Received April 16, 2013

    Report

    Report Number
    1627487-2013-12487
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    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

    RECALL NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORIES. 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 3. REFERENCE MFR. REPORTS: 1627487-2013-12488 AND 1627487-2013-12489. IT WAS REPORTED THE PT STOPPED USING THE SYS TWO YEARS AGO DUE TO INEFFECTIVE STIMULATION. THE PT ALSO EXPERIENCES PAIN AT THE IPG POCKET SITE. THE PHYSICIAN IS USING OTHER MODALITIES TO TREAT THE PT. THE PHYSICIAN ADVISED THE PT TO LEAVE THE SYS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163189 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3136616

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention