BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 3052897 · Received April 2, 2013

    Report

    Report Number
    1627487-2013-10108
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P0100032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    IT WAS REPORTED THE PT'S IPG HAD PREMATURELY DEPLETED (FRANCE). IT WAS NOTED THE DEPLETION IS THOUGHT TO BE RELATED TO A NON-DEVICE RELATED ACCIDENT THE PT HAD IN (B)(6) 2012. THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135393 GENESIS SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3608 3333150

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention