BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 17630172 · Received August 28, 2023

    Report

    Report Number
    3006630150-2023-05102
    Event Type
    Injury
    Date Received
    August 28, 2023
    Date of Event
    August 7, 2023
    Report Date
    August 28, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729837145
    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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: UPN: M365SC231670E0, MODEL: SC-2316-70E, SERIAL: (B)(6), LOT: 7082629. PRODUCT FAMILY: UPN: M365SC231670E0, MODEL: SC-2316-70E, SERIAL: (B)(6), LOT: 7082657.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRIAL SPINAL CORD STIMULATION (SCS) IMPLANT PROCEDURE. THE PATIENT WAS ADMINISTERED LOCAL ANESTHESIA DURING THE PROCEDURE. THE PHYSICIAN EXPERIENCED SIGNIFICANT DIFFICULTY WITH LEAD DRIVING AT THE ENTRY. SEVERE BLOCKAGES WERE NOTED BETWEEN THORACIC 12 TO THORACIC 10. THE PHYSICIAN WAS UNABLE TO ADVANCE PAST THORACIC 10. DURING THE PROCEDURE THE PATIENT SCREAMED AND JUMPED SUDDENLY ON THE TABLE. THE PHYSICIAN EXPLANTED THE LEADS, AND THE SURGERY WAS ABORTED. THE PATIENT HAD LIMITED FUNCTION AND MOVEMENT OF THEIR LEFT LEG AND EXPERIENCED INTENSE PAIN THAT SEEMED TO WORSEN. THE PATIENT WAS IMMEDIATELY SENT FOR A MAGNETIC RESONANCE IMAGING (MRI), WHICH RESULTED IN NO FINDINGS. PAIN INJECTION WAS ADMINISTERED ALONG WITH ORAL MEDICATION. THE TRIAL LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY. IT WAS LATER REPORTED THAT THE PATIENT IS STABLE, HAS FULL FUNCTIONALITY OF THEIR LEG, JUST INTENSE RESIDUAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703767 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-70E 7082343 08714729837145

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention