BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16 - CHANNEL RECHARGEABLE IPG

    MDR report key: 2211874 · Received August 10, 2011

    Report

    Report Number
    1627487-2011-07036
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 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 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

    THE PT RECEIVED A SCS SYSTEM ON (B)(6) 2006. IT WAS REPORTED ON (B)(6) 2011 THAT THE PT COULD NOT TURN STIMULATION UP TO PERCEPTION. X-RAYS OF THE PT WERE TAKEN AND NO ANOMALIES WERE NOTED. THERE WERE NO REPORTED FALLS/TRAUMATIC EVENTS. SJM REPRESENTATIVE WILL BE DISCUSSING OPTIONS WITH THE PT AND THE DOCTOR. NO FURTHER INFORMATION 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 3716 55891

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL: 3244| SCS EXTENSION: MODEL: 3383