BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4092178 · Received September 3, 2014

    Report

    Report Number
    1627487-2014-21586
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    July 21, 2014
    Report Date
    August 11, 2014
    Manufacturer
    ST. JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2014-21587. IT WAS REPORTED THE PATIENT ((B)(6)) EXPERIENCED LOSS OF STIMULATION. DIAGNOSTICS REVEALED MULTIPLE LOW IMPEDANCE VALUES. THE PATIENT ALSO STATED EXPERIENCING POCKET STIMULATION DURING PROGRAMMING. CONSULT WITH THE PHYSICIAN IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535377 EON SCS IPG GZB ST. JUDE MED - NEUROMODULATION 3716 113373

    Patients

    Seq Age Sex Outcome Treatment
    1 Other