BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON

    MDR report key: 3113029 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-03628
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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 THE PT IS EXPERIENCING INTERMITTENT COMMUNICATION BETWEEN HER SCS IPG AND CHARGING SYSTEM. SUBSEQUENTLY, A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT. FOLLOW-UP IDENTIFIED THE ISSUE DID NOT RESOLVE WITH THE REPLACEMENT CHARGING SYSTEM. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202530 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3161613

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS LEAD, MODEL 3186 (2)| SCS ANCHOR, MODEL 1192 (2)