BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2100780 · Received May 19, 2011

    Report

    Report Number
    1627487-2011-00688
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    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

    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 ON (B)(6) 2008. IT WAS REPORTED SHE HAS AN ALLERGIC REACTION PRESENT AT THE CURRENT IPG LOCATION. THE NURSE AT THE FACILITY INDICATED THAT THE REACTION WAS VISIBLE ALL OVER HER BODY. THE REPORTED REACTION BEGAN AFTER THE PATIENT WAS PRESCRIBED MORPHINE. SHE HAS BEEN REFERRED TO A PHYSICIAN FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 172238

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3219