BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2051297 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-01366
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S EVAL: THE RETURNED PRODUCT WAS NOT ANALYZED AS THE COMPLAINT CANNOT BE CONFIRMED VIA LABORATORY TESTING. EVAL RESULTS: AS RECEIVED, THE IPG WAS NOTED TO BE NON-RESPONSIVE. 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 HIS SCS SYSTEM, INCLUDING AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT THE PT'S IPG ENTERED THE "STIMULATION OFF" MODE, AND THE PT DID NOT RECHARGE THE IPG. IT WAS REPORTED THAT THE PT LOST STIMULATION APPROXIMATELY THREE MONTHS AGO, AND HE DID NOT RECHARGE IN OVER 45 DAYS. CONSEQUENTLY, THE PT PROGRAMMER AND CHARGING SYSTEM WERE UNABLE TO COMMUNICATE WITH THE IPG. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG WITH A DIFFERENT MODEL ON (B)(6) 2011. STIMULATION WAS ALLEGEDLY CAPTURED POSTOPERATIVE, AND NO FURTHER PT ISSUES WERE REPORTED.

    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 2833291

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention