BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 12929986 · Received December 3, 2021

    Report

    Report Number
    3006630150-2021-06927
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    October 18, 2021
    Report Date
    December 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138350, MODEL: SC-3138-35, SERIAL: (B)(4), BATCH: 7072776.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEAD EXHIBITED HIGH IMPEDANCES ON CONTACT 2. THE LEAD WAS IMPLANTED EPIDURAL IN THE CERVICAL AREA. THE PHYSICIAN NOTED THAT THEY HAD DIFFICULTY ADVANCING THE LEAD DUE TO SOME STENOSES IN THE SPINAL CANAL. THE PATIENT LATER REFUSED THIS FORM OF THE THERAPY FOR HIMSELF AND ALL IMPLANTED PRODUCTS WERE EXPLANTED. ALL EXPLANTED PRODUCTS WERE DISPOSED BY THE OPERATING ROOM NURSE. THE PATIENT IS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823538 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 7072581 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Unknown Required Intervention