BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 10242662 · Received July 7, 2020

    Report

    Report Number
    3006630150-2020-02796
    Event Type
    Injury
    Date Received
    July 7, 2020
    Date of Event
    June 12, 2020
    Report Date
    July 7, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(4); BATCH: 5062559.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LINEAR LEADS WERE REPLACED WITH INFINION LINEAR LEADS. DURING THE PROCEDURE, THE PATIENT HAD A SPINAL TAP. THE PHYSICIAN NOTED THAT THE PATIENT HAS A CLOTTING DISORDER AND WAS INSTRUCTED TO LAY FLAT AND DRINK CAFFEINE. THE PATIENTS PAIN AREAS WERE SUCCESSFULLY COVERED POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705137 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 21442498 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention