BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 2544566 · Received April 13, 2012

    Report

    Report Number
    1627487-2012-05551
    Event Type
    Malfunction
    Date Received
    April 13, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 23, 2012
    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 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 PT IS W/O STIMULATION. THE PT LOST HIS PROGRAMMER AND CHARGER A YR AGO. AN SJM REP PLANS TO MEET WITH THE PT FOR TROUBLESHOOTING. ATTEMPTS TO GATHER ADD'L INFO WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention