BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2092562 · Received May 3, 2011

    Report

    Report Number
    1627487-2011-00576
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT (B)(6) RECEIVED AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2007. IT WAS REPORTED THAT THE RECHARGE TIME AND RECHARGE BURDEN FOR HER IPG HAS INCREASED. IN AN EFFORT TO RESOLVE THIS MATTER, A NEW CHARGING SYSTEM WAS ISSUED TO THE PT. HOWEVER, THE REPORTED PROBLEM PERSISTS. THE PT DENIES EXPERIENCING ANY TRAUMA TO THE IPG SITE WHICH MAY HAVE CONTRIBUTED TO THIS MATTER. SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG, 16-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3716 55730

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention