BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 12091865 · Received June 30, 2021

    Report

    Report Number
    3006630150-2021-03347
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 10, 2021
    Report Date
    June 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729784067
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC221850E0, MODEL: SC-2218-50E, SERIAL: (B)(4), BATCH: 7087517/7122637.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS VOMITING ALL NIGHT FOLLOWING A TRIAL PROCEDURE WHICH WAS BELIEVED TO BE PROCEDURE RELATED. THE TRIAL LEADS WERE EXPLANTED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991674 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E 5087598 08714729784067

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention