BEUDAMED
    FDA Adverse Event Other Summary report: N

    EONC

    MDR report key: 2933145 · Received January 25, 2013

    Report

    Report Number
    1627487-2013-04090
    Event Type
    Other
    Date Received
    January 25, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 HAD RECEIVED A LOW BATTERY FLAG. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND CLEARED THE FLAG. THE SCS SYSTEM SETTINGS WERE REVIEWED, AND IT WAS DETERMINED THE ISSUE WAS PASSIVATION. FOLLOW UP IDENTIFIED THE FLAG HAD BEEN CLEARED A SECOND TIME, AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36185 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3346029

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention SCS LEAD, MODEL 3224| IMPLANT DATE: