BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4240482 · Received October 30, 2014

    Report

    Report Number
    1627487-2014-26907
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    ST. JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 IPG WAS UNABLE TO COMMUNICATE WITH THE EXTERNAL DEVICES. THE PATIENT REPORTS HE FORGOT TO RECHARGE HIS IPG FOR AN EXTENDED PERIOD OF TIME AND IT IS UNKNOWN WHEN THE IPG WAS LAST RECHARGED. THE IPG IS INOPERABLE. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REMOVE AND REPLACE HIS IPG WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696983 EON MINI SCS IPG GZB ST. JUDE MED - NEUROMODULATION 3788 3444813

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other IMPLANT DATE:| PNS LEAD: MODEL 3163| IMPLANT DATE:| SCS LEAD: MODEL 2345