BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3850588 · Received May 29, 2014

    Report

    Report Number
    1627487-2014-01355
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014. THE IPG WAS EXPLANTED AND REPLACED DUE TO ITS INABILITY TO MAINTAIN A CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317188 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 115165

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other IMPLANT DATE: UNK| SCS LEAD, MODEL 3244