BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 1990683 · Received February 8, 2011

    Report

    Report Number
    1627487-2011-01110
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 14, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE IPG DID NOT APPEAR TO BE CHARGING PROPERLY. IT WAS REPORTED THAT THE CHARGER SHOWED IT WAS FUNCTIONING, BUT AFTER CHARGING FOR SIX HOURS, THE PT PROGRAMMER REVEALED THAT THE IPG BATTERY WAS LOW. A REPLACEMENT CHARGER AND PROGRAMMER WERE UNSUCCESSFUL AT RESOLVING THE ISSUE. THE PT WAS STILL RECEIVING STIMULATION. FOLLOW UP ON THE PT ON (B)(6) 2011, FOUND THAT THE PROBLEM HAD NOT RESOLVED. IT WAS REPORTED THAT STIMULATION HAD CEASED, AND NO MATTER HOW LONG THE PT TRIED TO CHARGE, THE STIMULATION STAYED OFF. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG ON (B)(6) 2011. THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3788 3108397

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention