BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2892930 · Received December 28, 2012

    Report

    Report Number
    1627487-2012-15140
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-15141. IT WAS REPORTED THE PT FELT A SHOCKING SENSATION AROUND HER IPG POCKET SITE. THE SJM REP INTERROGATED THE SYSTEM AND ALL IMPEDANCES WHERE ACCEPTABLE. ADDITIONALLY, THE BATTERY LEVEL WAS LOW AND THE PT INDICATED THAT SHE HAD NOT USED HER SYSTEM FOR ALMOST FIVE MONTHS. REPROGRAMMING WAS ABLE TO PROVIDE STIMULATION, HOWEVER THE PT INDICATED THAT NOT ALL PAIN AREAS WERE FULLY COVERED. THE PT DID NOT REPORT ANY SHOCKING SENSATIONS WHILE THE SYSTEM WAS TURNED ON. PT WAS PROVIDED WITH BOTH VERBAL AND WRITTEN INSTRUCTIONS REGARDING PROPER CHARGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 2807948

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention