BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3954875 · Received July 16, 2014

    Report

    Report Number
    1627487-2014-21478
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. REF MFR REPORT: 1627487-2014-21479. THE PT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT (B)(6) EXPERIENCES PAIN AT THE LEAD SITE WHICH IS ALLEVIATED WITHOUT STIMULATION IDENTIFIED REPROGRAMMING WAS UNSUCCESSFUL AS THE PAIN DID NOT COMPLETELY RESOLVE. THE PT ALSO EXPERIENCES UNPLEASANT STIMULATION AT THE IPG SITE. DIAGNOSTICS INDICATED LOW LEAD IMPEDANCE ON SEVERAL CONTACTS. THE PT WAS GIVEN SEVERAL PROGRAMS TO REDUCE THE PAIN/SHARPNESS SENSATION. X-RAYS HAVE BEEN ORDERED AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415883 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3733687

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other IMPLANT DATE:| SCS EXTENSION: MODEL 3383 (2)