BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM 5 ELITE

    MDR report key: 8545656 · Received April 24, 2019

    Report

    Report Number
    3006705815-2019-01472
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    April 15, 2019
    Report Date
    April 30, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067020192
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS, METHOD AND CONCLUSION CODES ALONG WITH THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    DEVICE 2 OF 2, MFG REPORT REFERENCE: 1627487-2019-04820. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO GET A DRG SYSTEM. THE EXISTING IPG WAS REPLACED WITH A NEW IPG. THE EXISTING LEAD WAS LEFT IN PLACE AND TWO DRG LEADS WERE ADDED. EFFECTIVE THERAPY WAS RESTORED POST OPERATION.

    Description of Event or Problem · 1

    DEVICE 2 OF 2, MFG REPORT REFERENCE: 1627487-2019-04820.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337225 PROCLAIM 5 ELITE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3660 A000066146 05415067020192

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 3225, SCS LEAD