BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 15941167 · Received December 8, 2022

    Report

    Report Number
    3006630150-2022-06835
    Event Type
    Injury
    Date Received
    December 8, 2022
    Date of Event
    November 24, 2022
    Report Date
    December 7, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12320, MODEL: SC-1232, SERIAL: (B)(4), BATCH: 543763; PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7111843; PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7111579; PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7075736. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BSC FOR ANALYSIS AS THEY WERE KEPT BY THE HOSPITAL.

    Description of Event or Problem · 0

    THE PATIENT'S SPINAL CORD STIMULATION SYSTEM WAS EXPLANTED DUE TO AN INFECTION NEAR THE EPIDURAL SPACE. THE PATIENT'S SYMPTOMS INCLUDED BACK PAIN, HEADACHES AND FEVER. THE PATIENT WAS SUBSEQUENTLY PLACED ON ANTIBIOTICS AS A RESULT OF THE INFECTION. THE PHYSICIAN DOES NOT KNOW THE CAUSE OF THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441525 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 7075800 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention