BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2792048 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-06551
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 18, 2012
    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 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

    IT WAS REPORTED THE PT HAS BEEN EXPERIENCING OVERSTIMULATION AT THE IPG SITE. AN IMPEDANCE CHECK AND X-RAYS WERE PERFORMED AND NO ANOMALIES WERE FOUND. THE PT MAY UNDERGO SURGICAL INTERVENTION ON A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3699664

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SCS LEAD: MODEL 3228| SCS ANCHORS: MODEL 1194 (2)| IMPLANTED:| IMPLANTED: