BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 7902785 · Received September 24, 2018

    Report

    Report Number
    3006630150-2018-61026
    Event Type
    Injury
    Date Received
    September 24, 2018
    Date of Event
    August 6, 2018
    Report Date
    September 24, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2316-50E, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5071394, MODEL/CATALOG DESCRIPTION: INFINION 16 TRIAL LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A TRIAL PATIENT WAS EXPERIENCING BLEEDING AT THE LEAD IMPLANT SITE. SWELLING WAS NOTED. THE LEADS WERE REMOVED AND THE TRIAL WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742632 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 5069438 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention