BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 17649399 · Received August 30, 2023

    Report

    Report Number
    3006630150-2023-05176
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    August 11, 2023
    Report Date
    August 30, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: 7210265.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT STARTED BLEEDING PROFUSELY AND WAS HAVING PAIN WITH WEAKNESS DURING THE LEAD PULL. IT WAS NOTED THAT THE PATIENT WAS PREVIOUSLY ON A BLOOD THINNING MEDICATION. THE PATIENT WAS SENT TO THE EMERGENCY ROOM AND ALL THE SCANS CAME BACK NORMAL. THE PATIENT WAS DISCHARGED AND WAS DOING WELL. THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288259 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7208830 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention