BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 11021984 · Received December 16, 2020

    Report

    Report Number
    3006630150-2020-06232
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    November 29, 2020
    Report Date
    December 18, 2020
    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 · 0

    CORRECTION TO BLOCK B5: EDIT MADE TO DESCRIPTION OF EVENT OR PROBLEM CORRECTION TO BLOCK H10: ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS. UPDATE TO BLOCK H6: EVALUATION CONCLUSION CODES. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6) BATCH: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPOSITION TWO LEADS THAT MIGRATED AND CAUSED THE PATIENT DISCOMFORT AND PAIN IN THE STOMACH. FOLLOWING THE PROCEDURE THE PATIENT WAS NOTED TO BE DOING WELL.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7070861. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7071994. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7072157.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPOSITION THE LEADS THAT HAD MIGRATED AND CAUSED PATIENT TO EXPERIENCE PAIN AND DISCOMFORT. THE PATIENT WAS NOTED TO BE DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485161 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 5162482 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention