BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION 16

    MDR report key: 16909177 · Received May 11, 2023

    Report

    Report Number
    3006630150-2023-02664
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    April 24, 2023
    Report Date
    June 13, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729837145
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (SN:(B)(6)). THE RETURNED LEADS WERE ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC231670E0. MODEL: SC-2316-70E. SERIAL: (B)(4). BATCH: 7082139.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRIAL PROCEDURE, PATIENTS PULSE DROPPED ONCE PRONED AND SEDATED WITH A LOCAL ANESTHESIA. THE PHYSICIAN ATTEMPTED TO PLACE ONE TRIAL LEAD AND AT THIS TIME, PATIENT DEVELOPED WITH A SECOND DEGREE HEART BLOCK ON THE TABLE. A CLINICAL RESEARCH ASSOCIATE (CRA) WAS UNABLE TO ELEVATE THE PULSE RATE, HENCE THE PATIENT WAS REMOVED FROM THE TABLE, AN ELECTROCARDIOGRAM RUN ON PATIENT, AND WAS TRANSPORTED TO EMERGENCY DEPARTMENT (ED) VIA EMERGENCY MEDICAL SERVICES (EMS). THE PHYSICIAN BELIEVED IT WAS NOT RELATED TO THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRIAL PROCEDURE, PATIENTS PULSE DROPPED ONCE PRONED AND SEDATED WITH A LOCAL ANESTHESIA. THE PHYSICIAN ATTEMPTED TO PLACE ONE TRIAL LEAD AND AT THIS TIME, THE PATIENT DEVELOPED WITH A SECOND-DEGREE HEART BLOCK ON THE TABLE. A CLINICAL RESEARCH ASSOCIATE (CRA) WAS UNABLE TO ELEVATE THE PULSE RATE, HENCE THE PATIENT WAS REMOVED FROM THE TABLE, RUN AN ELECTROCARDIOGRAM, AND WAS TRANSPORTED TO EMERGENCY DEPARTMENT (ED) VIA EMERGENCY MEDICAL SERVICES (EMS). THE PHYSICIAN BELIEVED IT WAS NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915882 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-70E 7082054 08714729837145

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Required Intervention