BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 2850127 · Received November 27, 2012

    Report

    Report Number
    1627487-2012-11716
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    September 30, 2012
    Report Date
    October 31, 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 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'S IPG HAD REACHED NORMAL END OF LIFE, AND WAS DEPLETED. THE PHYSICIAN REPLACED THE IPG. THE SJM REPRESENTATIVE WAS UNABLE TO RETRIEVE THE IPG TO CONFIRM THE SETTINGS FOR NORMAL END OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3643 2758277

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANT DATE:| SCS LEAD, MODEL 3166 (2)