BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 8842405 · Received July 30, 2019

    Report

    Report Number
    3006630150-2019-03911
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    July 9, 2019
    Report Date
    July 30, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2316-50E, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5140897, MODEL/CATALOG DESCRIPTION: INFINION 16 TRIAL LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING SEVERE LEG PAIN FOLLOWING A TRAIL PROCEDURE. THE PATIENT WAS PROVIDED WITH MEDICATION. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637331 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 5140897 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention