BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESISXP PULSE GENERATOR, 8-CHANNEL

    MDR report key: 1970282 · Received January 14, 2011

    Report

    Report Number
    1627487-2011-00090
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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 PT WAS IMPLANTED WITH AN IPG ON (B)(6) 2005. IT WAS REPORTED THAT HIS IPG WAS EXPLANTED ON (B)(6) 2010 DUE TO BATTERY DEPLETION. NO PROGRAM PARAMETERS WERE PROVIDED TO DETERMINE IF THE IPG HAD REACHED ITS EXPECTED END-OF LIFE. THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESISXP PULSE GENERATOR, 8-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3609 34376A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention