BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18445839 · Received January 4, 2024

    Report

    Report Number
    3006630150-2023-08379
    Event Type
    Injury
    Date Received
    January 4, 2024
    Date of Event
    September 24, 2023
    Report Date
    January 31, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7111416.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE BSN SALES REPRESENTATIVE WAS PRESENT DURING THE SURGERY OF (B)(6) 2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES. IT WAS MENTIONED THAT REPROGRAMMING WAS ATTEMPTED. THE PHYSICIAN BELIEVED THAT THE LEAD HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. IT WAS NOTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS DISPLAYED HIGH IMPEDANCES. IN ADDITION, THE PHYSICIAN ASSESSED THAT THE LEADS HAD MIGRATED AS THERE WAS AN OFFSET IN THE LEAD POSITIONING. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE TWO SCS LEADS WERE REPLACED WITH AN SCS PADDLE LEAD. THE EXPLANTED LEADS WILL NOT BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559470 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7111415 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention