BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2003731 · Received February 23, 2011

    Report

    Report Number
    1627487-2011-00246
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-00247. THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2009 CONSISTING OF AN IPG AND SURGICAL LEAD FOR BACK AND BILATERAL LEG PAIN. IT WAS REPORTED THAT HE WAS WITHOUT STIMULATION AND UNABLE TO ESTABLISH COMMUNICATION WITH HIS IPG USING TWO PROGRAMMERS AND TWO CHARGING SYSTEMS. PRIOR TO THIS EVENT, THE PT HAD ALLEGEDLY EXPERIENCED OVERSTIMULATION. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO RECTIFY THIS ISSUE. INTRAOPERATIVE TESTING OF THE LEAD REVEALED INVALID IMPEDANCE MEASUREMENTS FOR SEVERAL CONTACTS. THE PT'S IPG AND LEAD WERE REPLACED AND EFFECTIVE STIMULATION WAS RECAPTURED AS A RESULT. THE EXPLANTED DEVICES WERE RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL -NEUROMODULATION DIV. 3788 2781230

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention