BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESISXP

    MDR report key: 2780284 · Received October 5, 2012

    Report

    Report Number
    1627487-2012-02431
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 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
    AL, 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 HAS NOT USED HER SCS SYSTEM SINCE 2010 BECAUSE THE SYSTEM STOPPED WORKING. SHE STATED HER IPG SITE IS CAUSING HER DISCOMFORT AND SHE IS IN A HOSPITAL BED ALL DAY. FOLLOW-UP IDENTIFIED THE PATIENT USED HER PROGRAMMER AND IT DISPLAYS AN "IPG BATTERY LOW" MESSAGE. SHE REPORTED SHE WAS ABLE TO ACHIEVE STIMULATION BUT IT ONLY WORKS FOR A FEW HOURS BEFORE SHUTTING OFF. IT WAS REPORTED THE PATIENT PLANS TO SEE A PHYSICIAN FOR A BATTERY REVISION CONSULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESISXP SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3609 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SCS LEAD, MODEL: 3186| IMPLANT DATE: