BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4112951 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-01599
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    May 1, 2014
    Report Date
    August 25, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFORMATION 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

    IT WAS REPORTED THE PT LAST RECHARGED THE IPG APPROXIMATELY 3 MONTHS AGO. AS A RESULT, THE PT IS WITHOUT STIMULATION. REPORTEDLY, THE IPG WILL NOT COMMUNICATE WITH THE CHARGER AND THE PT PROGRAMMER IS DISPLAYING AN ERROR MESSAGE. SURGICAL INTERVENTION MAY BE CONSIDERED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577215 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 173228

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other SCS LEAD: MODEL 3189| IMPLANT DATE:| SCS ANCHOR: MODEL 1194| IMPLANT DATE: