BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3032394 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-12410
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 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 INFO 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

    DEVICE 1 OF 2. REF MFR REPORT: 1627487-2013-12411. IT WAS REPORTED, THE PT EXPERIENCED INEFFECTIVE STIMULATION AND STOPPED USING AND CHARGING THE SCS SYSTEM. THE IPG BECAME DEPLETED. THE PT WAS RE-TRIALED. F/U REVEALED THE PHYSICIAN EXPLANTED AND REPLACED THE IPG. ALSO, TWO NEW LEADS WERE IMPLANTED. THE EXISTING LEAD WAS LEFT IN PLACE BUT WAS NOT CONNECTED TO THE NEW IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130645 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3121739

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)