BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3123487 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-04597
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    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 INCLUDED IN 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 3 OF 3. REF MFR REPORTS: 1627487-2013-04595, 1627487-2013-04596. IT WAS REPORTED THE PT WAS UNABLE TO FEEL STIMULATION ON THE RIGHT SIDE UNLESS SHE MOVED HER HEAD TO THE LEFT. THE SJM REP MET WITH THE PT AND DETERMINED THERE WAS ONE CONTACT ON A LEAD WHICH WAS INVALID. IN ADDITION, IT WAS REPORTED THE IPG POSITION WAS TO BE MOVED DUE TO LOSS OF WEIGHT. IT WAS REPORTED WHEN SITTING, THE PT FELT AS THOUGH SHE WAS SITTING ON THE IPG. FOLLOW-UP IDENTIFIED THE PHYSICIAN REPLACED BOTH LEADS. IT WAS REPORTED THE LEFT LEAD HAD INVALID IMPEDANCES AND THE RIGHT LEAD WAS NOT PROVIDING EFFECTIVE STIMULATION. IN ADDITION, THE PHYSICIAN REPOSITIONED THE IPG INTO A POCKET WHICH WAS HIGHER DUR TO THE DISCOMFORT. IT WAS REPORTED THE PT RECEIVED EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219202 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3117844

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention IMPLANT DATE:| SCS EXTENSION, MODEL 3346