BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 3810765 · Received April 28, 2014

    Report

    Report Number
    1627487-2014-03296
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S SCS IPG WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL DUE TO EXPERIENCING POCKET SITE DISCOMFORT AS THE ORIGINAL SCS IPG WAS "TOO LARGE" FOR THE PT. POST-OPERATIVE THE PT WAS NOT EXPERIENCING DISCOMFORT WITH THE NEW SCS IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254183 EONC SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3688 2832777

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other SCS LEAD: MODEL 3228| IMPLANT DATE: