BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 2212560 · Received August 11, 2011

    Report

    Report Number
    1627487-2011-04029
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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 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

    THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING IPG ON (B)(6) 2010. THE IPG POCKET WAS REVISED TO A DIFFERENT LOCATION FOR PATIENT COMFORT. IT WAS REPORTED THAT THE REVISION WAS SUCCESSFUL, AND NO FURTHER FOLLOW UP IS REQUIRED FOR THIS SCS SYSTEM. THE PATIENT HAD A SECOND SCS SYSTEM EXPLANTED ON (B)(6) 2011. REFER TO 1627487-2011-04026 AND 1627487-2011-04027 REGARDING THIS SECOND SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3117835

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention SCS LEAD: MODEL 3289| IMPLANT DATE: