BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 2971706 · Received January 30, 2013

    Report

    Report Number
    1627487-2013-15123
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER: 1627487-12192011-003-R. THE 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 HAS NOT CHARGED OR USED HER SYSTEM FOR AN EXTENDED PERIOD OF TIME. THE SJM REP MET WITH THE PT AND INDICATES THE IPG WILL NOT COMMUNICATE WITH EXTERNAL DEVICES. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41835 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2831144

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR SCS LEAD: MODEL 3186 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)