BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 2940660 · Received January 30, 2013

    Report

    Report Number
    1627487-2013-13140
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 11, 2013
    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 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

    IT WAS REPORTED THE PT EXPERIENCED WHAT HE DESCRIBED AS A BURNING SENSATION BELOW HIS IPG DRESSING SITE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40974 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3598569

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention IMPLANT DATE:| SCS LEAD, MODEL 3228| SCS ANCHOR, MODEL 1194 (2)| IMPLANT DATE: