BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 9182447 · Received October 11, 2019

    Report

    Report Number
    3006630150-2019-05707
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    August 12, 2019
    Report Date
    November 8, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5110245, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. MODEL NUMBER/CATALOG NUMBER: SC-4318, BATCH/LOT NUMBER: (B)(4), MODEL/CATALOG DESCRIPTION: CLIK ANCHOR STERILE KIT. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS AND ANCHOR REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS LEAD HAD MIGRATED. THE PHYSICIAN BELIEVED THAT THE LEADS WERE NOT IMPLANTED IN THE CORRECT LOCATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS LEAD HAD MIGRATED. THE PHYSICIAN BELIEVED THAT THE LEADS WERE NOT IMPLANTED IN THE CORRECT LOCATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974828 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5109791 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention