BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3931874 · Received June 20, 2014

    Report

    Report Number
    1627487-2014-15479
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 28, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AN 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2014-15478. IT WAS REPORTED THE PATIENT SUDDENLY LOST STIMULATION. PATIENT DENIED SUFFERING ANY FALLS. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND DIAGNOSTIC TESTING INDICATED INVALID IMPEDANCE READINGS ON ALL LEAD CONTACTS. X-RAYS WERE ORDERED, HOWEVER THE RESULTS ARE UNKNOWN. THE PATIENT ALSO EXPERIENCED DISCOMFORT AT THE IPG SITE DUE TO THE LOCATION OF THE IPG. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 AND INTRA-OPERATIVE TESTING INDICATED INVALID IMPEDANCE READINGS ON ALL LEAD CONTACTS. THE PHYSICIAN DID NOT WISH TO VIEW THE LEAD USING FLUOROSCOPY. THE PHYSICIAN ELECTED TO EXPLANT THE PATIENT'S IPG AND ALSO REMOVED THE TERMINAL ENDS OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364042 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3778 4434301

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other