BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3042328 · Received April 3, 2013

    Report

    Report Number
    1627487-2013-04401
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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 PATIENT HAD LEADS EXPLANTED IN (B)(6) 2012 (REFERENCE MFR REPORT: 211938-2013-3078). SINCE THE PROCEDURE, THE PATIENT REPORTED INABILITY TO COMMUNICATE WITH THE IPG USING THE CHARGING SYSTEM. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PATIENT. THE PATIENT REPORTED HE HAD NOT USED THE STIMULATION FOR ABOUT SIX WEEKS, AND HAD NOT CHARGED THE IPG PRIOR TO DISCONTINUING USE. IT WAS REPORTED THE SJM REPRESENTATIVE MET WITH THE PATIENT FOR TROUBLESHOOTING. IT WAS REPORTED THE COMMUNICATION ISSUE COULD NOT BE RESOLVED, AN THE PATIENT NO LONGER HAD STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137376 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3166352

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention SCS LEAD: MODEL 3163| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3166| SCS EXTENSION: MODEL 3341