BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM 7 ELITE

    MDR report key: 8640110 · Received May 24, 2019

    Report

    Report Number
    1627487-2019-06099
    Event Type
    Injury
    Date Received
    May 24, 2019
    Date of Event
    May 7, 2019
    Report Date
    June 26, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    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

    RELATED MFR. REPORT#: 3006705815-2019-001940; RELATED MFR. REPORT#: 3006705815-2019-001941. ADDITIONAL INFORMATION INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2019 WHEREIN THE PATIENT'S SYSTEM WAS EXPLANTED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2019-01940.RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2019-01941.

    Description of Event or Problem · 1

    REFERENCE MANUFACTURER REPORT NUMBER: 3006705815-2019-01940, REFERENCE MANUFACTURER REPORT NUMBER: 3006705815-2019-01941. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. SURGICAL INTERVENTION MAY BE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434695 PROCLAIM 7 ELITE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3662 6357879 05415067020222

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL: 3186 (X2), SCS LEAD