BEUDAMED
    FDA Adverse Event Other Summary report: N

    EONC

    MDR report key: 3240826 · Received July 18, 2013

    Report

    Report Number
    1627487-2013-00414
    Event Type
    Other
    Date Received
    July 18, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LOW BATTERY MESSAGE WAS OBSERVED FOR THE PT'S ((B)(6)) IPG DURING POST-OPERATIVE PROGRAMMING. THE MESSAGE WAS SUCCESSFULLY CLEARED. A F/U CLINICAL APPOINTMENT HAS BEEN SCHEDULED FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335266 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3751243

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR