BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 2210430 · Received August 9, 2011

    Report

    Report Number
    1627487-2011-08031
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    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) 2007. IT WAS REPORTED THAT THE IPG REQUIRED LONG AND FREQUENT RECHARGING. SOME OF THE IPG PROGRAMS CONTAINED HIGH PARAMETER SETTINGS. THE DEVICE WAS SCHEDULED TO BE REPROGRAMMED. THE DEVICE IS STILL IN USE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 97363

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention