BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EONC

    MDR report key: 3240977 · Received July 18, 2013

    Report

    Report Number
    1627487-2013-16025
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 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 PATIENT RECEIVED A LOW BATTERY ERROR ON HER PROGRAMMER. SHE STATED SHE IS STILL ABLE TO ADJUST HER STIMULATION APPROPRIATELY. SURGICAL INTERVENTION WILL LIKELY BE UNDERTAKEN TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335254 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3254445

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR SCS LEAD: MODEL 3228| IMPLANT DATE: