BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2980052 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-02256
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    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 INFO 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

    DEVICE 2 OF 2. REF MFR REPORT: 1627487-2013-02255. THE PT HAS TWO SCS SYSTEMS. IT WAS REPORTED THE PT EXPERIENCED DISCOMFORT AT BOTH OF HER IPG SITES DUE TO THE SIZE OF THE IPGS. THE PHYSICIAN EXPLANTED AND REPLACED BOTH IPGS WITH A SMALLER MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77342 EON SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3716 113541

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3286 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3244| IMPLANT DATE:| SCS LEAD: MODEL 3245| SCS EXTENSION: MODEL 3382 (2)