BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2100613 · Received May 17, 2011

    Report

    Report Number
    1627487-2011-01537
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 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 HIS SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF BURNING AND DISCOMFORT AT THE IPG POCKET SITE, AND HE REQUESTED THE REMOVAL OF THE IPG. HE ALLEGED THAT THE IPG HEATED UP WHEN IN USE. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG ON (B)(6) 2011. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    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 3788 3290658

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention