BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 9858652 · Received March 20, 2020

    Report

    Report Number
    3006630150-2020-01321
    Event Type
    Injury
    Date Received
    March 20, 2020
    Date of Event
    February 26, 2020
    Report Date
    March 20, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER:SC-2317-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7070796, MODEL/CATALOG DESCRIPTION:INFINION CX LEAD KIT, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN EROSION AT THE LEAD SITE. THE PATIENTS WOUND WAS CLEANED AND CLOSED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325897 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5180787 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention