BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3202183 · Received June 28, 2013

    Report

    Report Number
    1627487-2013-05940
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 4, 2013
    Report Date
    March 17, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-072602012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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

    IT WAS REPORTED THE PT HAS LOST STIMULATION DUE TO THE CHARGER AND PROGRAMMER NO LONGER COMMUNICATING WITH THE IPG. AN AFFILIATED SJM REP ATTEMPTED TO ADDRESS THE ISSUE WITH TWO REPLACEMENT CHARGERS BUT WAS UNSUCCESSFUL. THE PT WILL MEET WITH AN SJM REP FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295918 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3148354

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other IMPLANT:| IMPLANT:| SCS ANCHORS: MODEL: 1194 (X2).| SCS LEAD: MODEL: 3228.| SCS LEAD: MODEL: 3228| SCS ANCHORS: MODEL: 1194 (X2)| IMPLANT:| IMPLANT: