BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3082449 · Received April 16, 2013

    Report

    Report Number
    1627487-2013-01439
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    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 MFR REPORT: 1627487-2013-1440. IT WAS REPORTED THE PATIENT IS EXPERIENCING RANDOM, SPORADIC SHOCKS AT THE LEAD AND IPG SITES WHEN THE STIMULATION IS ON. THE SHOCKS ARE FELT AT THE IPG AND LEAD SITE AT THE SAME TIME. THE PATIENT ALSO REPORTS GETTING A MUSCLE CRAMP IN HER LEFT CALF WHEN STIMULATION IS TURNED ON. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND REPROGRAMMED HER. X-RAYS HAVE BEEN ORDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163068 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3792813

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)