BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2193561 · Received July 14, 2011

    Report

    Report Number
    1627487-2011-03281
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 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 A SCS SYSTEM ON (B)(6) 2006. IT WAS REPORTED THAT THE PT FELT LIKE STIMULATION IS RUNNING EVEN THOUGH THE STIMULATION IS OFF AND THE SYSTEM HAS NOT BEEN USED FOR (B)(6). IT WAS CONFIRMED BY SJM REP THAT THE STIMULATION WAS OFF. THE PT IS GOING TO CONTACT THE DOCTOR TO DISCUSS THE PROBLEM. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 49436

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SCS LEAD: MODEL 3289| IMPLANT DATE:| SCS LEAD: MODEL 3086| IMPLANT DATE: