BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 1962647 · Received January 13, 2011

    Report

    Report Number
    1627487-2011-00078
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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 #1627487-2011-00079. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2009 CONSISTING OF AN IPG AND TWO PERCUTANEOUS LEADS. IT WAS REPORTED THAT SHE SUSPENDED USE OF HER SCS SYSTEM APPROX SIX MONTHS AGO DUE TO INEFFECTIVE THERAPY COVERAGE. DURING THE PERIOD OF INACTIVITY, THE IPG WAS ALLEGEDLY NOT RECHARGED. RECENT EFFORTS TO COMMUNICATE WITH THE DEVICE VIA THE PROGRAMMER AND CHARGING SYSTEM PROVED UNSUCCESSFUL. IN ADDITION, AN X-RAY OF THE PT'S SCS SYSTEM REVEALED THAT ONE OF HER LEADS HAS MIGRATED. AT THIS TIME, THERE ARE NO IMMEDIATE PLANS FOR SURGICAL INTERVENTION.

    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 DIVISION 3788 2831145

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention