BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2476780 · Received February 23, 2012

    Report

    Report Number
    1627487-2012-09235
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    January 26, 2012
    Report Date
    January 26, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGZ
    PMA / PMN Number
    P010032
    Product Problem
    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 HAS BEEN REPORTED THE PT HAS NOT USED, CHARGED AND COMMUNICATED WITH HIS SCS SYS IN ABOUT TWO YEARS DUE TO A LACK OF SEVERITY IN PAIN AND UNRELATED SURGERIES. THE PT RECENTLY DECIDED TO USE THE SYS AND FOUND IT TO BE NON-RESPONSIVE. THE PT IS W/O STIMULATION. A SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG, 16-CHANNEL SCS IPG LGZ ST. JUDE MEDICAL - NEUROMODULATION 3716 119609

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SCS LEAD: MODEL 3186| IMPLANT DATE: