BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3891719 · Received June 9, 2014

    Report

    Report Number
    1627487-2014-26490
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 19, 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
    MD, 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

    THE PT REPORTED SHE WAS UNABLE TO COMMUNICATE WITH THE IPG USING HER CHARGING SYSTEM. PT DENIES WEIGHT FLUCTUATIONS. THE PT STATED THAT SHE FEELS AS IF THE IPG WAS SITTING SIDEWAYS AND CLOSE TO THE SKIN. IN ADDITION, SHE STATES SHE CAN FEEL THE EDGE OF HER IPG. THE PT ADDED SPACE BETWEEN HER IPG AND CHARGING SYSTEM WHICH DID NOT RESOLVE THE ISSUE. THE PT REPORTS SHE WAS ABLE TO COMMUNICATE WITH IPG WITH HER PROGRAMMER. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT. FOLLOW UP INFO IDENTIFIED THE PT EXPERIENCED DIFFICULTY IN RECHARGING AND SHE FEELS AS IF THE IPG HAS FLIPPED IN THE POCKET. THE PT IS ABLE TO COMMUNICATE WITH IPG WITH THE CHARGING SYSTEM AND IS ONLY ABLE TO INTERMITTENTLY RECHARGE THE IPG. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2014 TO REPOSITION THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334380 EON MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3788 425499

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SCS LEAD: MODEL 3228| IMPLANT DATE: