BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 2092647 · Received May 10, 2011

    Report

    Report Number
    1627487-2011-01498
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    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 HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2009. IT WAS REPORTED THAT THE PT EXPERIENCED A HEATING SENSATION AT THE IPG POCKET SITE ONLY WHILE CHARGING THE IPG. SHE STATED THAT THIS ISSUE OCCURRED AFTER 3-4 MINUTES OF CHARGING. THE PT REPORTED THAT THE HEATING SENSATION STARTED TO OCCUR GRADUALLY, AND IT HAS BEEN MORE INTENSE OVER THE PAST FEW MONTHS. A NEW CHARGING SYSTEM WAS SENT TO THE PT. F/U ON THE PT FOUND THAT THE ISSUE RESOLVED WITH THE NEW CHARGER. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION 3716 119589

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SCS LEAD: MODEL 3156| IMPLANT:| SCS LEAD EXTENSION: MODEL 3341| IMPLANT: