BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2193132 · Received July 21, 2011

    Report

    Report Number
    1627487-2011-02901
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THE PT COULD NOT GET STIMULATION ON ONE LEAD IN THE RECOVERY ROOM DUE TO HIGH IMPEDANCES. AN X-RAY WAS TAKEN AND IT WAS DISCOVERED THAT THE LEAD HAD DISCONNECTED FROM THE IPG. THE PHYSICIAN RECONNECTED THE IPG ON THE FOLLOWING DAY RESTORING IMPEDANCE AND STIMULATION TO THE PT. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL ¿ NEUROMODULATION 3788 3308526

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCS LEAD: MODEL 2X 3186| IMPLANT: