BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3141823 · Received May 28, 2013

    Report

    Report Number
    1627487-2013-12731
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    December 1, 2012
    Report Date
    May 2, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 1 OF 2. REF MFR REPORT #1627487-2013-12732. IT WAS REPORTED THE PT DID NOT RECEIVE PAIN RELIEF FROM THE SCS SYSTEM. THE PT ALSO REPORTED HE THEN DID NOT USE OR CHARGE THE IPG SYSTEM FOR FIVE MONTHS. AS A RESULT, THE IPG BATTERY IS DEPLETED. THE PT DOES NOT WANT ANY INTERVENTION TO ADDRESS THE ISSUE AT THIS TIME. NOTE: THE PT HAS TWO LEADS WITH THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233426 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 31995163

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention SCS ANCHOR, MODEL 1192 (2)| IMPLANT DATE: