BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESISXP

    MDR report key: 3133293 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-03663
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    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

    THE RETURNED PRODUCT WAS NOT ANALYZED AS THE COMPLAINT OF INFECTION COULD NOT BE CONFIRMED VIA LABORATORY TESTING. EVALUATION METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. HOWEVER, THE INDIVIDUAL AFFECTED DEVICE WAS REWORKED AND ALL DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE, THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED REDNESS AROUND HER SCS IPG POCKET SITE AFTER THE IPG WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. IT WAS ALSO REPORTED THE PATIENT IS BEING TREATED FOR AN INFECTION AT THE POCKET SITE AND IS RECEIVING ORAL ANTIBIOTICS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223328 GENESISXP SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3644 34479A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SCS LEAD, MODEL 3146 (2)| IMPLANT DATE: