BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESISXP IMPLANTABLE PULSE GENERATOR

    MDR report key: 1910253 · Received November 18, 2010

    Report

    Report Number
    1627487-2010-03584
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2008. IT WAS REPORTED THE IPG POCKET SITE WAS CAUSING THE PATIENT DISCOMFORT. AS THE PATIENT'S PAIN HAD BEEN SUBSIDED AND SHE WAS NO LONGER USING THE IPG, IT WAS EXPLANTED AND NOT REPLACED. THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS; HOWEVER, ANALYSIS IS IN PROGRESS AT THIS TIME. FOLLOW UP ON THE PATIENT 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 116035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention