BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3961057 · Received July 15, 2014

    Report

    Report Number
    1627487-2014-24018
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    April 7, 2014
    Report Date
    June 24, 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 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 2 OF 2. REFER TO MFR REPORT 1627487-2014-24017. THE PATIENT RECEIVED TWO SCS LEADS WITH THE SAME LOT NUMBERS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AUTO-REDUCTION. DIAGNOSTICS INDICATED MULTIPLE INVALID LEAD IMPEDANCES AND ONE LOW LEAD IMPEDANCE CONTACT. REPROGRAMMING WAS UNSUCCESSFUL AS STIMULATION COULD NOT COVER THE PATIENT'S PAIN AREAS. X-RAYS DID NOT REVEAL ANY ANOMALIES. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE LEAD ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413199 EON MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3788 3290658

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192,