BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG

    MDR report key: 4093188 · Received September 9, 2014

    Report

    Report Number
    MW5038189
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    July 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    ST JUDE
    Product Code
    GZB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ONGOING ISSUE OF DEVICE SHUTTING ITSELF DOWN. REQUIRES USE OF MAGNETS TO REACTIVATE. SUGGESTING SERIOUS ISSUES WITH PRINTED CIRCUIT BOARD AND SOLDERING WELDS. PT IN CONTACT WITH TECHNICAL SUPPORT AND REP, BUT THIS INFO NOT PASSED ON TO THE IMPLANTING PHYSICIAN. CONCERN WITH QUALITY CONTROL AT ST. JUDE. I HAVE FOUND OUT THAT THIS DEVICE IS INCLUDED ON A SERIOUS MEDICAL DEVICE RECALL LIST. THIS INFO SHOULD HAVE BEEN COMMUNICATED IN (B)(6), AND NOT THROUGH COMMUNICATION WITH THE PT THREE MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556300 EON MINI IPG SPINAL CORD STIMULATOR GENERATOR GZB ST JUDE 3788 2842398

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SYNCHROMED II INTRATHECAL PUMP WITH DILAUDID| 400 MCG/DAY