BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2172583 · Received July 20, 2011

    Report

    Report Number
    1627487-2011-06014
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    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 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 THE SECOND OF TWO SCS SYSTEMS ON (B)(6) 2009 INCLUDING AN IPG. IT WAS REPORTED THAT HE LOST STIMULATION AND WAS UNABLE TO COMMUNICATE WITH THE IPG VIA EITHER THE CHARGING SYSTEM OR THE PT PROGRAMMER. ATTEMPTS TO RECTIFY THIS MATTER WITH THE USE OF A NEW CHARGING SYSTEM WERE UNSUCCESSFUL. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO REPLACE THE PT'S IPG.

    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 2831145

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention IMPLANTED:| SCS IPG: MODEL 3788| SCS LEADS: MODEL 3189 (2)| SCS LEADS: MODEL 3186 (2)| IMPLANTED:| SCS LEAD ANCHORS: MODEL 1194 (2)| IMPLANTED:| IMPLANTED:| IMPLANTED:| SCS LEAD ANCHORS: MODEL 1194 (2)