BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCS IPG

    MDR report key: 7011725 · Received November 8, 2017

    Report

    Report Number
    1627487-2017-07015
    Event Type
    Injury
    Date Received
    November 8, 2017
    Report Date
    November 8, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. THE THERAPY DATE AND MODEL FOR THE CONCOMITANT DEVICES(S) IS UNKNOWN. THE MANUFACTURER 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. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION AT THE IPG SITE. AS SUCH, SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE ENTIRE SYSTEM WAS EXPLANTED. THE PATIENT IS REPORTEDLY HEALING WELL. THE PATIENT'S DEVICE DETAILS ARE UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790294 SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other