BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 9837114 · Received March 16, 2020

    Report

    Report Number
    3006630150-2020-01208
    Event Type
    Injury
    Date Received
    March 16, 2020
    Date of Event
    February 22, 2020
    Report Date
    April 15, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366700. MODEL: SC-2366-70. SERIAL: (B)(6). BATCH: 5139816. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 5136405. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366500 MODEL: SC-2366-50 SERIAL: (B)(6), BATCH: 5163247.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE IN WHICH A LEAD WAS REPOSITIONED DUE TO LEAD MIGRATION. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED UNDESIRED SENSATIONS IN A NON-TARGET STIMULATION AREA BECAUSE OF THE LEAD MIGRATION. THE PATIENT INDICATED THAT THE STIMULATION IS NOW IN THE CORRECT AREA AND COVERING THE PATIENTS CHRONIC PAIN AREA. XRAYS WERE TAKEN HOWEVER THE RESULTS WERE NOT MADE AVAILABLE. NO DEVICES WERE RETURNED FOR EVALUATION AS THEY REMAIN IMPLANTED AND IN SERVICE. IT IS UNCLEAR WHICH OF THE FOUR IMPLANTED LEADS WAS REPOSITIONED DURING THE REVISION PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE IN WHICH A LEAD WAS REPOSITIONED DUE TO LEAD MIGRATION. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300487 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 5139817

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention