BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 15353344 · Received September 2, 2022

    Report

    Report Number
    3006630150-2022-04492
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    August 8, 2022
    Report Date
    October 21, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789567
    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-LINEAR LEADS. UPN: M365SC2366700. MODEL: SC-2366-70. SERIAL: (B)(4). BATCH: 5142041.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAD MIGRATION OF THE TWO SPINAL CORD STIMULATION (SCS) LEADS AND THE LEADS NO LONGER COVERED THE PATIENTS INITIAL PAIN AREA. ADDITIONALLY, ONE LEAD EXHIBITED A HIGH IMPEDANCE MEASUREMENT. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE TWO LEADS WERE EXPLANTED AND REPLACED. THE PATIENT HAS FULLY RECOVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAD MIGRATION OF THE TWO SPINAL CORD STIMULATION (SCS) LEADS AND THE LEADS NO LONGER COVERED THE PATIENT'S INITIAL PAIN AREA. ADDITIONALLY, ONE LEAD EXHIBITED A HIGH IMPEDANCE MEASUREMENT. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE TWO LEADS WERE EXPLANTED AND REPLACED. THE PATIENT HAS FULLY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ONSET DATE OF THE LEAD MIGRATION WAS SEVERAL WEEKS PRIOR TO THE REVISION PROCEDURE. NO EXACT DATE COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2368892 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 5142042 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention