BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 10498128 · Received September 5, 2020

    Report

    Report Number
    1627487-2020-31101
    Event Type
    Injury
    Date Received
    September 5, 2020
    Report Date
    November 4, 2020
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05415067020222
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    RELATED MFR REPORTS: 1627487-2020-31102 AND 162487-2020-31103

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    RELATED MFR REPORTS: 1627487-2020-31102 AND 162487-2020-31103. IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS REMOVED DUE TO LACK OF EFFICACY. THE PATIENT STATED THE PERMANENT IMPLANT WAS NOT AS SUCCESSFUL AS THE TRIAL. REPORTEDLY, THE LEADS WERE IN THE SAME PLACE AS THE TRIAL. THE SCS SYSTEM DID NOT WORK FOR THE PATIENT IN SPITE OF THE THERAPY BEING MAPPED TO THE PATIENT'S PAIN AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962389 PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3662 6659513 05415067020222

    Patients

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