BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM 7 ELITE

    MDR report key: 8927909 · Received August 23, 2019

    Report

    Report Number
    1627487-2019-09190
    Event Type
    Injury
    Date Received
    August 23, 2019
    Date of Event
    August 8, 2019
    Report Date
    September 12, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05415067020222
    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

    IT WAS REPORTED THE PATIENT'S IPG WOULD NOT COMMUNICATE WITH THE EXTERNAL DEVICES. A MANUFACTURER REPRESENTATIVE CONFIRMED THE ISSUE AND THE IPG WAS DEEMED INOPERABLE. PATIENT ALSO REPORTED EXPERIENCING INEFFECTIVE STIMULATION (REFERENCE REG REPORT:1627487-20119-09189), (REFERENCE REG REPORT:3006705815-2019-03086) (REFERENCE REG REPORT:3006705815-2019-03087). IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED, POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720509 PROCLAIM 7 ELITE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3662 6054906 05415067020222

    Patients

    Seq Age Sex Outcome Treatment
    1 Other