BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG

    MDR report key: 1924854 · Received December 9, 2010

    Report

    Report Number
    1627487-2010-03483
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    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 RECEIVED HER SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT SHE UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2010 TO INCREASE THE IMPLANT DEPTH OF HER IPG DUE TO DISCOMFORT AT THE POCKET SITE. NO DEVICES WERE EXPLANTED AND NONE WERE RETURNED TO THE MFR FOR EVAL. FOLLOW-UP ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 2880146

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention