BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 13941006 · Received March 29, 2022

    Report

    Report Number
    3006630150-2022-01313
    Event Type
    Injury
    Date Received
    March 29, 2022
    Date of Event
    November 10, 2021
    Report Date
    March 29, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7081805.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A VERY SENSITIVE MIDLINE INCISION SOMEWHERE AT THE BELOW AREA THAT STARTED SINCE THE TRIAL PROCEDURE. IT WAS ALSO NOTED THAT THE PATIENT CRIED BECAUSE IT HURTS WHEN TOUCHED AND WHEN LAYING DOWN. THE PHYSICIAN ASSISTANT SUGGESTED TO INCREASE THE DOSAGE OF HER NERVE PAIN MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748008 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7081762 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention