BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3950180 · Received June 27, 2014

    Report

    Report Number
    1627487-2014-23427
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    March 1, 2014
    Report Date
    June 3, 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

    IT WAS REPORTED THE PATIENT WAS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HER IPG AND EXTERNAL DEVICES. THE PATIENT REPORTED SHE HAD NOT CHARGED IT IN APPROXIMATELY 3 MONTHS. THE PATIENT MET WITH THE SJM REPRESENTATIVE AND CONFIRMED THE ISSUE. FOLLOW-UP INFORMATION REVEALED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014, WHERE THE IPG WAS REMOVED AND REPLACED WITH A NEW ONE, WHICH RESOLVED THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376699 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3520147

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other SCS ANCHOR: MODEL 1192 (2)| SCS LEAD: MODEL 3186 (2)| IMPLANT DATE:| IMPLANT DATE: