BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3001672 · Received March 5, 2013

    Report

    Report Number
    1627487-2013-01247
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING NUMBER: 1627487-12192011-003-R. 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 IS UNABLE TO COMMUNICATE WITH OR CHARGE HIS IPG. THE PT LAST CHARGED HIS IPG TWO MONTHS AGO. THE PT IS PENDING FOLLOW UP WITH HIS PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93477 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2789907

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SCS LEAD: MODEL 3219| IMPLANT DATE: