BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 10245989 · Received July 8, 2020

    Report

    Report Number
    3006630150-2020-02810
    Event Type
    Injury
    Date Received
    July 8, 2020
    Date of Event
    June 18, 2020
    Report Date
    July 8, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4,) MODEL: SC-2316-50E, SERIAL: (B)(4), BATCH: 7091701.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A TRIAL PROCEDURE, THE PATIENT WAS EXPERIENCING INTENSE LUMBAR PAIN. THE PATIENT WAS GIVEN POST OPERATIVE PAIN MEDICATIONS, HOWEVER, THEY WERE NOT WORKING. THE PHYSICIAN DECIDED TO EXPLANT THE LEADS AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE PHYSICIAN BELIEVED THAT THE PATIENTS REACTION WAS NOT SPECIFIC TO OUR DEVICE BUT TO SPINAL CORD STIMULATOR (SCS) IN GENERAL. THE EXPLANTED LEADS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709196 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7091446 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention