BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 15997518 · Received December 16, 2022

    Report

    Report Number
    3006630150-2022-07051
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    November 23, 2022
    Report Date
    December 16, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 : (B)(4). MODEL : SC-2316-50E. SERIAL: (B)(4). BATCH: 7180263.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDNESS AND IRRITATION DUE TO AN ALLERGIC REACTION WITH THE ADHESIVE THAT WAS USED TO KEEP THE LEADS. THE PATIENT UNDERWENT A LEAD PULL. THE EXPLANTED COMPONENTS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2588687 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7175179 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention