BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 8953843 · Received September 2, 2019

    Report

    Report Number
    3006630150-2019-04718
    Event Type
    Injury
    Date Received
    September 2, 2019
    Date of Event
    August 12, 2019
    Report Date
    September 2, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5140715, MODEL/CATALOG DESCRIPTION:LINEAR ST LEAD KIT 50 CM. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATE TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE LEADS WAS FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A POSSIBLE INFECTION AT THE MIDLINE INCISION SITE. THE PHYSICIAN BELIEVED THAT IT WAS NOT PROCEDURE RELATED AND THE CAUSED WAS UNKNOWN. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747691 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5140710 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention