BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 10695578 · Received October 19, 2020

    Report

    Report Number
    3006630150-2020-04922
    Event Type
    Injury
    Date Received
    October 19, 2020
    Date of Event
    August 26, 2020
    Report Date
    October 16, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: (B)(4). MODEL: SC-2352-50. SERIAL: 7071491. BATCH: 7071491.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE PHYSICIAN FOUND OUT THAT THE PATIENT HAD AN INFECTION AT THE LOW BACK. IT WAS NOTED THAT PATIENT WAS ASYMPTOMATIC AND THAT THE INFECTION WAS NOT PROCEDURE RELATED. THE IMPLANT PROCEDURE WAS CANCELLED AND THE PATIENT WAS PLACED ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166790 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 7071500 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention