BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2930549 · Received January 24, 2013

    Report

    Report Number
    1627487-2013-13117
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    DEVICE 1 OF 2. REF MFR REPORT: 1627487-2013-13118. THE PT HAS TWO IPGS, BOTH ARE BEING REPORTED SINCE IT IS UNKNOWN WHICH IPG IS RELATED TO THIS EVENT. IT WAS REPORTED THE PT HAD GAINED SOME WEIGHT AND FELT HER IPG MAY HAVE SHIFTED SLIGHTLY. IT WAS ALSO REPORTED THE PT UNDERWENT A SURGICAL PROCEDURE TO REPOSITION HER RIGHT HIP IPG. THE PT WAS DOING WELL POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33652 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3376723

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention SCS LEAD, MODEL 3166 (2)| IMPLANT DATE:| SCS EXTENSION, MODEL 3346 (3)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD, MODEL 3169 (4)