BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MININ

    MDR report key: 3851355 · Received May 22, 2014

    Report

    Report Number
    1627487-2014-25396
    Event Type
    Injury
    Date Received
    May 22, 2014
    Report Date
    May 1, 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 STOPPED RECEIVING STIMULATION AND HAS BEEN UNABLE TO CHARGE THE IPG FOR 2 TO 3 MONTHS. AN SJM REPRESENTATIVE MET WITH THE PATIENT FOR TROUBLESHOOTING AND IDENTIFIED MULTIPLE REPLACEMENT CHARGERS WERE UNABLE TO COMMUNICATE WITH THE IPG. ADDITIONALLY, MULTIPLE PROGRAMMERS WERE USED AND CONFIRMED STIMULATION IS OFF. THE PATIENT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE. FOLLOW-UP REVEALED THE PATIENT'S IPG WAS EXPLANTED AND REPLACED. EFFECTIVE STIMULATION WAS RESTORED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306180 EON MININ SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3553124

    Patients

    Seq Age Sex Outcome Treatment
    1 Other IMPLANT:| IMPLANT:| SCS ANCHORS, MODEL: 1192 (X2)| SCS LEADS, MODEL:3186 (X2)