BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 8162904 · Received December 13, 2018

    Report

    Report Number
    3006630150-2018-62272
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 29, 2018
    Report Date
    December 13, 2018
    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

    CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-2316-50E, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5100115, MODEL/CATALOG DESCRIPTION: INFINION 16 TRIAL LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A TRIAL PROCEDURE THE PHYSICIAN NOTICED CEREBROSPINAL FLUID WHEN PLACING THE LEADS, SO BLOOD PATCH WAS DONE. THE PATIENT EXPERIENCED PAIN AT THE RIGHT LOW BACK AND LOWER EXTREMITIES. THE PATIENT WAS PRESCRIBED PAIN MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999003 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 5100113 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention