BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 4583886 · Received March 9, 2015

    Report

    Report Number
    1627487-2015-03069
    Event Type
    Injury
    Date Received
    March 9, 2015
    Date of Event
    February 11, 2015
    Report Date
    May 30, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE COMPLAINT FOR SUDDEN LOSS OF STIMULATION WAS CONFIRMED. THE IPG WAS ABLE TO COMMUNICATE WITH ALL LAB UTILITIES. THE IPG WAS FUNCTIONALLY TESTED AND PASSED ALL TESTING. THE IPG CHARGED NORMALLY WITH LAB EQUIPMENT. THE BOTTOM SEPTUM WAS CORED AND HEAVILY DISCOLORED. VISUAL INSPECTION OF THE DEVICE FOUND THAT THE LOWER HEADER CHAMBER HAD EXCESS BODY FLUID. THE CORED SEPTUM WOULD HAVE ALLOWED FLUID TO MIGRATE INTO THE HEADER ASSEMBLY, WHICH WOULD HAVE CREATED AN ADDITIONAL CURRENT PATH FOR STIMULATION. THE LEAKAGE CURRENT AT THE HEADER COULD HAVE RESULTED IN THE SUDDEN LOSS OF STIMULATION THE PATIENT WAS EXPERIENCING. 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.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTIONS/REMOVAL REPORTING NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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 (NETHERLANDS) EXPERIENCED SUDDEN LOSS OF STIMULATION AND NOW THE SCS IPG IS INOPERABLE. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE SCS IPG WAS EXPLANTED AND REPLACED. STIMULATION WAS RESTORED WITH THE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160733 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3148238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other