BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 12423784 · Received September 3, 2021

    Report

    Report Number
    3006630150-2021-04953
    Event Type
    Injury
    Date Received
    September 3, 2021
    Date of Event
    July 27, 2021
    Report Date
    September 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC231650E0, MODEL: SC-2316-50E, SERIAL: (B)(4), BATCH: 7131627.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A SPINAL CORD STIMULATION TRIAL PROCEDURE, THE PATIENT WAS EXPERIENCING WEAKNESS IN THE LEGS AND WAS SENT TO THE EMERGENCY ROOM (ER). THE PATIENT UNDERWENT A PROCEDURE TO PULL THE LEADS EARLY. THE PATIENT WAS TREATED WITH CIPRO. THE PATIENT RECEIVED A DIAGNOSIS OF A CEREBROVASCULAR ACCIDENT (CVA). IT WAS NOTED THAT THE WEAKNESS IN THE LEGS WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND IS AT HOME RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317550 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7131567 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention