BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 12088869 · Received June 29, 2021

    Report

    Report Number
    3006630150-2021-03328
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    April 13, 2021
    Report Date
    June 29, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789567
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT(S) INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7070663. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7070652. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7070949.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED INADEQUATE STIMULATION. XRAY EXAMINATION CONFIRMED THAT THE LEADS HAD MIGRATED. RE-PROGRAMMING WAS ATTEMPTED AND WAS ABLE TO IMPROVE THE PATIENT'S COVERAGE SOMEWHAT BUT NOT TO HOW IT WAS PRIOR. IT WAS ALSO NOTED THAT THE LEFT MEDIAL LEAD HAD HIGH IMPEDANCE AT CONTACT TWO. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE PHYSICIAN ATTEMPTED TO RE-POSITION THE THREE OUT OF FOUR LEADS THAT HAD MIGRATED, BUT THEN THE PHYSICIAN DECIDED TO REPLACE THE THREE LEADS. IT IS UNKNOWN EXACTLY WHICH THREE OUT OF THE FOUR IMPLANTED LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POST OPERATIVELY AND ALL IMPEDANCES WERE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984728 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 7071833 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention