BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 4173525 · Received October 10, 2014

    Report

    Report Number
    1627487-2014-05702
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    ST. JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN FIELD ADVISORIES. 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

    IT WAS REPORTED THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED. IN TURN, THE PATIENT LOST STIMULATION DUE TO THE IPG BEING INOPERABLE AND UNABLE TO COMMUNICATE WITH THE EXTERNAL DEVICES. AS A RESULT, THE PATIENT WILL UNDERGO SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642943 EON MINI SCS IPG GZB ST. JUDE MED - NEUROMODULATION 3788 3161705

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR SCS LEAD: MODEL 3219| IMPLANT DATE: