BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 2820151 · Received November 2, 2012

    Report

    Report Number
    1627487-2012-00739
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODUALTION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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'S (B)(6) IPG WAS REPLACED DUE TO A MALFUNCTIONING CONTACT. THE CORRESPONDING CONTACT ON THE LEAD WAS REPORTEDLY FUNCTIONING WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS SCS IPG LGW ST. JUDE MEDICAL - NEUROMODUALTION 3608 3333147

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention