BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 8287158 · Received January 29, 2019

    Report

    Report Number
    3006630150-2019-00294
    Event Type
    Injury
    Date Received
    January 29, 2019
    Date of Event
    January 11, 2019
    Report Date
    January 29, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2317-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5092448, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING NUMBNESS AND PAIN DOWN HER LEFT LEG. CT SCAN SHOWED IT WAS JUST IRRITATION OF THE NERVES FROM PLACING THE LEADS. THE PATIENT WAS PLACED ON A REHAB FACILITY AND WAS GIVEN ALL PROGRAMS. IT WAS ALSO REPORTED THAT ALL TEST PERFORMED WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78475 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5092395 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R