BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 18185025 · Received November 21, 2023

    Report

    Report Number
    3006630150-2023-07251
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    October 26, 2023
    Report Date
    February 20, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC231650E0. MODEL: SC-2316-50E. SERIAL: (B)(6). BATCH: 7211909.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC231650E0, MODEL: SC-2316-50E, SERIAL: (B)(6), BATCH: (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC231650E0. MODEL: SC-2316-50E. SERIAL: (B)(6). BATCH: 7211909.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY (A7007 ENVISION) SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED INADEQUATE PAIN RELIEF DUE TO LACK OF EFFICACY AND HAD AN ADDITIONAL LEAD TRIAL. THERE WAS NO REPORTED DEVICE DEFICIENCY AND THE PATIENT WAS UNDERGOING AN ADDITIONAL TRIAL FOR COVERAGE IMPROVEMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT THE TWO SCS LEADS FOR AN UNKNOWN REASON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY (A7007 ENVISION) SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED INADEQUATE PAIN RELIEF DUE TO LACK OF EFFICACY AND HAD AN ADDITIONAL LEAD TRIAL. THERE WAS NO REPORTED DEVICE DEFICIENCY AND THE PATIENT WAS UNDERGOING AN ADDITIONAL TRIAL FOR COVERAGE IMPROVEMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT THE TWO SCS LEADS FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CLINICAL STUDY SITE CONFIRMED THAT THE REPORTED EXPLANT PROCEDURE WAS ASSOCIATED WITH THE LEAD PULL FOR THE ADDITIONAL LEAD TRIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY (A7007 ENVISION) SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED INADEQUATE PAIN RELIEF DUE TO LACK OF EFFICACY AND HAD AN ADDITIONAL LEAD TRIAL. THERE WAS NO REPORTED DEVICE DEFICIENCY AND THE PATIENT WAS UNDERGOING AN ADDITIONAL TRIAL FOR COVERAGE IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879913 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7215563 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention