BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2831844 · Received November 9, 2012

    Report

    Report Number
    1627487-2012-10629
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 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
    BE
    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'S STIMULATION WOULD STOP INTERMITTENTLY (B)(6), IT WAS ALSO REPORTED THE STIMULATION WOULD INTERMITTENTLY START ON ITS OWN. SURGICAL INTERVENTION WAS PERFORMED ON (B)(6) 2012. THE PHYSICIAN CONCLUDED THAT THE IPG WAS THE SOURCE OF THE ISSUE AS THERE WERE NO PROBLEMS DETECTED WITH THE LEADS, LEAD EXTENSION OR PATIENT PROGRAMMER. THE IPG WAS IMPLANTED IN 2011 (EXACT DATE UNKNOWN). THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE STIMULATION WAS RESTORED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3495381

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention