BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2180647 · Received May 5, 2011

    Report

    Report Number
    1627487-2011-00618
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 7, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    THE PT RECEIVED AN SCS SYSTEM INCLUDING AN IPG ON (B)(4) 2009. IT WAS REPORTED THAT HE WAS WITHOUT STIMULATION AND UNABLE TO COMMUNICATE WITH HIS IPG VIA EITHER THE CHARGING SYSTEM OR THE PROGRAMMER. IN AN EFFORT TO RESOLVE THIS MATTER, A REPLACEMENT CHARGING SYSTEM WAS SHIPPED TO THE PT. NO FURTHER INFO IS AVAILABLE AT THIS TIME AS ALL ATTEMPTS TO CONFIRM RESOLUTION HAVE BEEN UNSUCCESSFUL. ACCORDING TO THE MANUFACTURER'S REGISTRATION'S RECORDS, THE PT'S IPG REMAINS IMPLANTED.

    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 2799145

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SCS LEAD: MODEL 3214| IMPLANTED: