BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 19381502 · Received May 23, 2024

    Report

    Report Number
    3006630150-2024-03324
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    May 2, 2024
    Report Date
    May 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC231650E0. MODEL: SC-2316-50E. SERIAL: (B)(6). BATCH: 7212604. PRODUCT FAMILY: SCS-SURG ACC. UPN: UNK-M-SC-4200. MODEL: SC-4200.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNCONTROLLED BLEEDING FROM THE NEEDLE SITE AT THE CONCLUSION OF THE TRIAL. THERE WAS NO BLEEDING NOTED FROM THE NEEDLES OR THE NEEDLE SITE DURING THE PROCEDURE. ONCE THE NEEDLES WERE REMOVED, THERE WAS A CONTINUOUS OOZING OF BLOOD FROM THE SITE WHERE THE NEEDLES WERE PLACED. THE PHYSICIAN APPLIED DIRECT PRESSURE AND USED ICE BUT IT WAS UNSUCCESSFUL. THE TRIAL LEADS WERE REMOVED AND WAS DETERMINED THAT THE BLEEDING WAS FROM A SUPERFICIAL ARTERY THAT HAD BEEN PIERCED BY THE INSERTION NEEDLE DURING THE PROCEDURE. THE PHYSICIAN PLACED TWO SUTURES TO TIE OFF THE ARTERY AND STOP THE BLEEDING. ALL LEADS WERE DISCARDED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154823 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7236895 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention