BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 8190878 · Received December 21, 2018

    Report

    Report Number
    3006630150-2018-62430
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    December 2, 2018
    Report Date
    December 21, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2316-50E, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5090419, 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 HOSPITALIZED DUE TO FLUID AROUND THE LUNGS. IT WAS NOTED THAT THE PATIENT'S HEART VALVE WAS THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030370 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 5037059 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R