BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESISXP IMPLANTABLE PULSE GENERATOR

    MDR report key: 2002316 · Received January 27, 2011

    Report

    Report Number
    1627487-2011-02096
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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

    THE PT REC'D AN SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2004. IT WAS REPORTED THE PT IS NO LONGER RECEIVING STIMULATION FROM HER IPG DUE TO SUSPECTED BATTERY DEPLETION. THE PT IS CONTINUING TO WORK WITH HER PHYSICIAN TO CONFIRM THE BATTERY DEPLETION. IT IS UNK IF THE IPG WILL BE RETURNED TO THE MANUFACTURER IF IT IS EXPLANTED. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESISXP IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION 3609 25475A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention