BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 10706350 · Received October 20, 2020

    Report

    Report Number
    3006630150-2020-05007
    Event Type
    Injury
    Date Received
    October 20, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 20, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7080698. PRODUCT FAMILY: SCS-IPG-R, UPN: (B)(4), MODEL: SC-1160, SERIAL: (B)(4), BATCH: 366146.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN THE MIDLINE INCISION SITE. SYMPTOMS OF DRAINAGE AND INCISION NOT CLOSING AT THE BOTTOM OF THE MIDLINE WERE ALSO REPORTED. IT WAS UNKNOWN WHAT CAUSED THE INFECTION AND IT WAS NOT BELIEVED TO BE DEVICE OR PROCEDURE RELATED. ALL COMPONENTS WERE EXPLANTED AND WERE NOT RETURNED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169262 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7080367 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention