BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 3012184 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-02361
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    April 2, 2012
    Report Date
    April 2, 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 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 LOST STIMULATION DUE TO BATTERY DEPLETION. THE IPG WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL ON (B)(6) 2012. THE EXPLANTED DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104343 GENESIS SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3643 3254447

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3156 (2)