BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2771971 · Received October 2, 2012

    Report

    Report Number
    1627487-2012-06491
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 12, 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
    AR, 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 HAS FALLEN ON NUMEROUS OCCASIONS. THE PATIENT FEELS THE IPG MAY HAVE MOVED IN THE POCKET. IT WAS ALSO REPORTED THE PATIENT IS EXPERIENCING PAIN AND DISCOMFORT AT THE IPG SITE. THE PATIENT HAS NOT USED THE SCS SYSTEM SINCE A YEAR AND A HALF AGO. AS A RESULT, THE CHARGER CAN NO LONGER COMMUNICATED WITH THE IPG. A NEW CHARGER WAS SENT TO THE PATIENT TO HELP RESOLVE THE ISSUE, BUT WAS UNSUCCESSFUL. THE PATIENT PLANS TO SCHEDULE AN APPOINTMENT WITH HER DOCTOR FOR FURTHER TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 86252

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention IMPLANT:| SCS LEAD, MODEL: 3245