BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3022428 · Received March 22, 2013

    Report

    Report Number
    1627487-2013-06093
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 1, 2013
    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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-06094. IT WAS REPORTED THE PATIENT¿S IPG HAS SHIFTED UP TOWARD THE SURFACE OF THE SKIN AND IS CAUSING PAIN AT THE IPG SITE. ADDITIONALLY, THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY FOR LOWER EXTREMITY BILATERAL COVERAGE FROM THE SYSTEM. THE PATIENT HAS ALREADY BEEN REPROGRAMMED ONCE, BUT THE PARESTHESIA HAS CHANGED. THE PATIENT IS NOT INTERESTED IN HAVING X-RAY TO DETERMINE IF THE LEAD HAS MIGRATED. FOLLOW-UP INDICATES THE PATIENT HAS BEEN SCHEDULED FOR A FULL SYSTEM EXPLANT. SURGERY INTERVENTION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119681 EON MINI SCS IPG LGW ST. JUDE MEDICAL NEUROMODULATION 3788 3881659

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention