BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 10601285 · Received September 29, 2020

    Report

    Report Number
    3006630150-2020-04518
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    March 4, 2020
    Report Date
    September 29, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED TWO WEEKS AFTER THE IMPLANT PROCEDURE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7071775.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED BACK TO ITS ORIGINAL LOCATION. THE LEAD REMAINS IMPLANTED IN THE PATIENTS BODY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065576 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7071772 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention