BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3110700 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-05660
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    THE PRODUCT THE PT HAS FOR OFF-LABEL USE IS UNK. IT WAS REPORTED ONE OF THE PT'S LEADS WAS NOT PROVIDING ADEQUATE COVERAGE DUE TO ITS LOCATION. ON (B)(6) 2013, THE LEAD WAS REPOSITIONED AND RESOLVED THE PT'S ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205034 UNK SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention