BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM 5 ELITE

    MDR report key: 8724565 · Received June 21, 2019

    Report

    Report Number
    3006705815-2019-02277
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    May 17, 2019
    Report Date
    July 1, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND HEATING AT THE IPG SITE. THE PATIENT HAD A FALL ABOUT TWO AND A HALF WEEKS PRIOR TO REPORTING THE ISSUE. AS A RESULT, THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2019. THE PATIENT HAS EFFECTIVE THERAPY POST OPERATIVELY. ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518522 PROCLAIM 5 ELITE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3660 A000064342 05415067020192

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other