BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4240517 · Received October 30, 2014

    Report

    Report Number
    1627487-2014-26913
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ST. JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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

    DEVICE #1 OF 3. REFERENCE MFR. REPORT: 1627487-2014-26914,26915. THE PATIENT REPORTED SHE UNDERWENT SURGICAL INTERVENTION TO REMOVE HER SCS SYSTEM BECAUSE SHE DID NOT LIKE THE SCS SYSTEM AND SHE DID NOT RECEIVE EFFECTIVE STIMULATION. IN ADDITION, THE IPG SITE WAS ALSO BOTHERING HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696529 EON SCS IPG GZB ST. JUDE MED - NEUROMODULATION 3716 174138

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other