BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 20221340 · Received September 15, 2024

    Report

    Report Number
    3006630150-2024-06135
    Event Type
    Injury
    Date Received
    September 15, 2024
    Date of Event
    August 21, 2024
    Report Date
    November 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SC-2316-50E, UPN: SC-2316-50E, MODEL: SC-2316-50E, SERIAL: (B)(6), BATCH: 7251035.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING CSF LEAK DURING A TRIAL PROCEDURE. THE PHYSICIAN ADMINISTERED BLOOD PATCH, AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE TRIAL PERIOD, THE PATIENT EXPERIENCED HEADACHES AS A RESULT OF A CEREBROSPINAL FLUID (CSF) LEAK. FOLLOWING THE REMOVAL OF PATIENTS TRIAL LEADS, THE PATIENT WAS EXPERIENCING SYMPTOMS OF SWELLING IN THE AREA WHERE THE BLOOD PATCH WAS PLACED DURING THE TRIAL. THE PATIENT WAS HOSPITALIZED AND WAS PLACED ON ANTIBIOTICS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS TRIAL LEADS WERE EXPLANTED AND DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING CSF LEAK DURING A TRIAL PROCEDURE. THE PHYSICIAN ADMINISTERED BLOOD PATCH, AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE TRIAL PERIOD, THE PATIENT EXPERIENCED HEADACHES AS A RESULT OF A CEREBROSPINAL FLUID (CSF) LEAK. FOLLOWING THE REMOVAL OF PATIENTS TRIAL LEADS, THE PATIENT WAS EXPERIENCING SYMPTOMS OF SWELLING IN THE AREA WHERE THE BLOOD PATCH WAS PLACED DURING THE TRIAL. THE PATIENT WAS HOSPITALIZED AND WAS PLACED ON ANTIBIOTICS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING CSF LEAK DURING A TRIAL PROCEDURE. THE PHYSICIAN ADMINISTERED BLOOD PATCH, AND THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638915 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2316-50E 7251032 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention