BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 2940675 · Received January 30, 2013

    Report

    Report Number
    1627487-2013-02151
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 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
    TX, US
    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 IPG WOULD NO LONGER COMMUNICATE AND THE BATTERY WAS DEPLETED. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG WITH A DIFFERENT MODEL ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40287 GENESIS SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3643 3254447

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention SCS LEAD: MODEL: 3156 (2)| IMPLANT DATE: