BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG

    MDR report key: 2120968 · Received June 9, 2011

    Report

    Report Number
    1627487-2011-02812
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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

    DEVICE 1 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01644. THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG AND SURGICAL LEAD, ON (B)(6) 2011. ON (B)(6) 2011, IT WAS REPORTED THAT THE STIMULATION HAD SLOWLY DECREASED UNTIL THE PATIENT COULD NOT FEEL IT AT ALL. X-RAYS SHOWED THAT THE LEAD HAD NOT MIGRATED. FOLLOW UP ON THE PATIENT FOUND THAT ANOTHER X-RAY WAS TAKEN OF THE IPG HEADER, AND THE LEAD WAS OBSERVED TO BE PULLED OUT OF THE IPG. THE PHYSICIAN PLANS TO PERFORM AN EXPLANT/REPLACEMENT PROCEDURE; HOWEVER, A SURGERY DATE HAS NOT BEEN SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3258995

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention