BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2013185 · Received March 8, 2011

    Report

    Report Number
    1627487-2011-01205
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 10, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 ((B)(6)) RECEIVED HER SCS INCLUDING AN IPG AND SURGICAL LEAD ON (B)(6) 2010. IT WAS REPORTED THAT THE PT HAS AN ALLERGY TO METAL AND WAS EXPERIENCING IRRITATION AT THE IPG POCKET SITE. THE PT REPORTED THAT THE SYMPTOMS BEGAN APPROX 2.5 MONTHS AFTER THE IMPLANT DATE. SHE ALLEGEDLY COMPLAINED OF PAIN BEHIND AND AROUND THE IPG SITE IN THE LEFT BUTTOCK AREA. IT WAS REPORTED THAT THE IPG POCKET SITE DID NOT APPEAR RED AND THE PT DID NOT HAVE A FEVER; HOWEVER, THE SKIN AROUND THE POCKET SITE FELT WARM AND THE PT HAD SEVERE ITCHING AT THE SITE. IT WAS REPORTED THAT THE ITCH WAS TREATED WITH AERIUS 5 MG FOR 20 DAYS. THE PHYSICIAN PLANS TO EITHER REVISE THE IPG SITE OR EXPLANT THE IPG DEPENDING ON WHETHER THE PT'S SYMPTOMS RESOLVE. THE PROCEDURE DATE IS CURRENTLY UNDETERMINED; NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    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 3063048

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention