BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 2850128 · Received November 27, 2012

    Report

    Report Number
    1627487-2012-11717
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    September 14, 2012
    Report Date
    November 1, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 PATIENT HAD LOST 42 POUNDS AND FELT PAIN AT THE IPG SITE WHETHER THE STIMULATION WAS ON OR OFF. THE PATIENT REPORTED THE PAIN WAS PRESENT WHEN SHE WENT FROM A SITTING POSITION TO A STANDING POSITION. THE PHYSICIAN EXAMINED THE IPG SITE AND PRESCRIBED LIDODERM PATCHES AND AN ANTI-INFLAMMATORY. FURTHER FOLLOW UP IDENTIFIED THE PHYSICIAN HAD MET WITH THE PATIENT AND WAS TO UNDERTAKE SURGICAL INTERVENTION AT A FUTURE DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3376675

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention SCS LEAD, MODEL 3228| IMPLANT DATE: