BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2182571 · Received July 5, 2011

    Report

    Report Number
    1627487-2011-00910
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT HE IS WITHOUT STIMULATION AND UNABLE TO COMMUNICATE WITH THE IPG USING EITHER HIS PROGRAMMER OR CHARGING SYSTEM. IN AN EFFORT TO RESOLVE THIS MATTER, A NEW CHARGING SYSTEM WAS SHIPPED TO THE PT. FOLLOW-UP ON THIS MATTER FOUND THAT THE REPORTED ISSUE PERSISTS WITH USE OF THE REPLACEMENT CHARGING SYSTEM. NO FURTHER INFORMATION IS AVAILABLE.

    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 3788 2786987

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention IMPLANTED:| SCS LEAD, MODEL: 3181