BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 3810738 · Received April 28, 2014

    Report

    Report Number
    1627487-2014-05303
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 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 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'S IPG WAS RELOCATED ON (B)(6) 2014, DUE TO DISCOMFORT AT THE IPG SITE. DURING THE PROCEDURE, TWO EXTENSIONS WERE IMPLANTED TO ACCOMMODATE THE NEW LOCATION OF THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253973 EONC SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3688 3614958

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other SCS LEAD: MODEL 3219| IMPLANT: