BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 11457109 · Received March 10, 2021

    Report

    Report Number
    3006630150-2021-00884
    Event Type
    Injury
    Date Received
    March 10, 2021
    Date of Event
    February 8, 2021
    Report Date
    March 10, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: 7113846.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TRIAL PERIOD THE PATIENT WAS EXPERIENCING PAIN WHEN WALKING. THE PATIENT UNDERWENT LEAD PULL PROCEDURE. THE EXPLANTED DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347870 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7113178 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention