BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 10378977 · Received August 7, 2020

    Report

    Report Number
    3006630150-2020-03303
    Event Type
    Injury
    Date Received
    August 7, 2020
    Date of Event
    July 15, 2020
    Report Date
    August 7, 2020
    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

    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: 7091056.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A TRIAL IMPLANT PROCEDURE, THE PATIENT WAS EXPERIENCING PAIN THAT WENT DOWN THE ENTIRE LEG TO THE FOOT. THE TRIAL PROCEDURE WAS ABORTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842855 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7090311 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention