BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 17322662 · Received July 14, 2023

    Report

    Report Number
    3006630150-2023-04077
    Event Type
    Injury
    Date Received
    July 14, 2023
    Date of Event
    June 24, 2023
    Report Date
    July 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7122263. PRODUCT FAMILY: SCS-IPG-PC, UPN: M365SC14160, MODEL: SC-1416, SERIAL: (B)(6), BATCH: 214401.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT WENT TO THE EMERGENCY ROOM AND WAS DIAGNOSED WITH SEPSIS AND A COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED AN ABSCESS AROUND THE LEAD SITE. AS SUCH, THE PATIENT WAS SCHEDULED FOR AN EXPLANT PROCEDURE HOWEVER, THE PATIENT DIED BEFORE THE EXPLANT COULD TAKE PLACE. NO FURTHER INFORMATION REGARDING THE CAUSE OF THE PATIENTS DEATH WAS ABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT WITH DIAGNOSIS OF SEPSIS AND COMPUTED TOMOGRAPHY SCAN SHOWED ABSCESS AROUND THE LEAD SITE. NO DEVICE MALFUNCTION WAS SUSPECTED. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185237 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7122152 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male Hospitalization| L| D| R