BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 12016466 · Received June 17, 2021

    Report

    Report Number
    3006630150-2021-03010
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    January 4, 2019
    Report Date
    June 17, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED SINCE PATIENT'S IMPLANT BACK IN 2019. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS- LINEAR LEADS: UPN: M365SC2218700, MODEL: SC- 2218-70, SERIAL: (B)(4), BATCH: 5092245.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS PHYSICIAN PLACED THE LEADS IN AN INCORRECT PAIN LOCATION. THE PATIENT UNDERWENT A DEVICE REPOSITIONING PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913706 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 5092214 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention