BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2080620 · Received April 25, 2011

    Report

    Report Number
    1627487-2011-00541
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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 PATIENT RECEIVED AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG POCKET. THE REPORTED DISCOMFORT WAS SAID TO BE PRESENT REGARDLESS OF THE STIMULATION'S FUNCTION. THE PATIENT'S IPG WAS REPLACED WITH A SMALLER MODEL AND EFFECTIVE STIMULATION WAS CAPTURED. NO FURTHER COMPLICATIONS WERE REPORTED.

    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 85481

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention