BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 8927891 · Received August 23, 2019

    Report

    Report Number
    3006705815-2019-03087
    Event Type
    Injury
    Date Received
    August 23, 2019
    Date of Event
    August 8, 2019
    Report Date
    September 12, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    (REFERENCE REG REPORT: 1627487-20119-09189) (REFERENCE REG REPORT: 3006705815-2019-03086). IT WAS REPORTED THE PATIENT EXPERIENCE INEFFECTIVE STIMULATION. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2019, WHEREIN THE ENTIRE SCS SYSTEM WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED, POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720000 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000039688 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 Other