BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 4852841 · Received June 18, 2015

    Report

    Report Number
    1627487-2015-25108
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 28, 2015
    Report Date
    December 10, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT (B)(6) EXPERIENCES INTERMITTENT STIMULATION. ADDITIONALLY, THE PATIENT'S IPG IS UNABLE TO COMMUNICATE WITH THE CHARGER OR PROGRAMMER, HOWEVER, AFTER A FEW HOURS STIMULATION WILL TURN ON AND THE IPG WILL COMMUNICATE WITH BOTH EXTERNAL DEVICES. THE PATIENT HAS STATED THE ISSUE OCCURS EVERY DAY. LEAD DIAGNOSTICS REVEALED NO ANOMALIES. IN TURN, THE PATIENT WILL UNDERGO SURGICAL INTERVENTION. CONCOMITANT MEDICAL PRODUCTS: THE IMPLANT DATE FOR THE FOLLOWING DEVICES IS UNKNOWN: MODEL: 3228, SCS LEAD; MODEL: UNKNOWN (X2), SCS EXTENSIONS.

    Description of Event or Problem · 1

    FOLLOW-UP REVEALED THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT AND REPLACE THE IPG WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398418 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4404384

    Patients

    Seq Age Sex Outcome Treatment
    1 Other