BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 2062186 · Received March 17, 2011

    Report

    Report Number
    1627487-2011-02328
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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

    THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2010. IT WAS REPORTED THE PATIENT PASSED THROUGH A SECURITY SENSOR WHILE WALKING INTO A STORE. HIS STIMULATION THEN SPONTANEOUSLY TURNED ON. THE PATIENT ATTEMPTED TO DISABLE THE STIMULATION WITH THE DEVICE MAGNET BUT WAS UNABLE TO ELICIT A RESPONSE FROM THE IPG. SINCE THAT TIME, THE PATIENT REPORTED, THE IPG WILL NOT RESPOND TO THE DEVICE MAGNET. A STRONGER MAGNET WAS SENT TO THE PATIENT BUT WAS UNABLE TO CORRECT THE ISSUE. THE PHYSICIAN RECOMMENDED AN IPG REPLACEMENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3194884

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention SCS LEAD: MODEL 3245| SCS LEAD: MODEL 3183| IMPLANT:| IMPLANT: