BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4091934 · Received August 27, 2014

    Report

    Report Number
    1627487-2014-06244
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    DEVICE 1 OF 5. REFERENCE MFR REPORT: 1627487-2014-06245. REFERENCE MFR REPORT: 1627487-2014-06246. REFERENCE MFR REPORT: 1627487-2014-06247. REFERENCE MFR REPORT: 1627487-2014-06248. IT WAS REPORTED THE PT IS EXPERIENCING PAIN AND DISCOMFORT AT THE IPG AND LEAD SITES. THE PT ALSO ALLEGES HER SCS SYSTEM HAS NEVER WORKED AND SHE DID NOT RECEIVE EFFECTIVE STIMULATION. THE PT REPORTED SURGICAL INTERVENTION IS PENDING TO REMOVE HER ENTIRE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522788 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 117384

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other