BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 12109811 · Received July 2, 2021

    Report

    Report Number
    3006630150-2021-03446
    Event Type
    Injury
    Date Received
    July 2, 2021
    Date of Event
    June 14, 2021
    Report Date
    July 2, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7072526. THE LEADS ARE NOT AVAILABLE FOR RETURN; THEREFORE, A TECHNICAL PRODUCT ANALYSIS OF THE DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. THEREFORE, THIS INVESTIGATION IS UNABLE TO DETERMINE A PROBABLE CAUSE FOR THE EVENT OF A REVISION PROCEDURE DUE TO THE DISCOMFORT FROM THE TIP OF THE LEAD, AS THE CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT WHEN HE TURNED IN BED OVER THE LEFT LEAD. THE PATIENT STATED THAT IT FELT LIKE THE TIP OF THE LEAD WAS POKING HIM. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE LEAD. THE PATIENT IS DOING WELL POSTOPERATIVELY AND GETTING GOOD COVERAGE OF HIS PAIN AREA. THE EXPLANTED DEVICE WAS RETAINED BY THE FACILITY AND WILL NOT BE RETURNED. THE BOSTON SCIENTIFIC REPRESENTATIVE IS UNSURE OF THE SERIAL NUMBER OF THE LEFT LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008651 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 7071995 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention