BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESISXP CONVENTIONAL IPG

    MDR report key: 2120249 · Received June 7, 2011

    Report

    Report Number
    1627487-2011-01604
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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

    THE PT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2006. IT WAS REPORTED THAT THE PT WAS RECEIVING INEFFECTIVE STIMULATION COVERAGE. THE PT REPORTED THAT IT HAD BEEN APPROXIMATELY TWO YEARS SINCE HE HAD USED HIS SYSTEM, CITING CARDIAC ISSUES AS THE ISSUE. FOLLOW UP ON THE PT FOUND THAT HIS PHYSICIAN PLANS TO EXPLANT THE SYSTEM AND RE-TRIAL THE PT. THE SURGERY DATE IS CURRENTLY UNDETERMINED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESISXP CONVENTIONAL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3609 35377A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS LEAD: MODEL 3245