BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON

    MDR report key: 3231017 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-11018
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 WAS REPORTED THE PT HAS TO RECHARGE THE IPG MORE FREQUENTLY THAN NORMAL. LONGEVITY CALCIFICATIONS REVEALED THE PT IS EXPERIENCING NORMAL DEVICE CHARACTERISTICS. IT IS UNK HOW OFTEN THE PT USED TO RECHARGE HIS IPG. AS A RESULT, THE PT MAY UNDERGO SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323202 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 50584

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR SCS LEAD: MODEL 3186| IMPLANT: