BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 3110942 · Received May 8, 2013

    Report

    Report Number
    1627487-2013-10148
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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

    DEVICE 3 OF 3. REF MFR REPORTS: 1627487-2013-10146, 1627487-2013-10147. IT WAS REPORTED THE PT'S ((B)(6)) STIMULATION IS NOT AS EFFECTIVE AS IT USED TO BE AND IS BEING DELIVERED TO UNINTENDED AREAS. IN ADDITION, THE PT REPORTED FEELING STIMULATION AFTER THE IPG HAD BEEN TURNED OFF. DIAGNOSTIC TESTING REVEALED INVALID IMPEDANCES. THE NEXT PLANNED COURSE OF ACTION IS TO OBTAIN X-RAYS IN AN ATTEMPT TO DETERMINE THE CAUSE OF THE REPORTED ISSUE. PLEASE NOTE: IMPLANT DATES AND ADDITIONAL DEVICE INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202215 GENESIS SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention