BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 10676551 · Received October 14, 2020

    Report

    Report Number
    3006630150-2020-04838
    Event Type
    Injury
    Date Received
    October 14, 2020
    Date of Event
    June 23, 2020
    Report Date
    October 14, 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: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7071889.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING NUMBNESS WHICH TURNED INTO PAIN IN THE LEGS AFTER LYING ON HER BACK. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN ONE LEAD WAS REMOVED. SINCE PATIENT HAD A VERY TIGHT EPIDURAL SPACE, THE PHYSICIAN BELIEVED THAT REMOVING ONE LEAD WOULD ALLOW FOR MORE SPACE AND WOULD NOT CREATE PRESSURE IN THE EPIDURAL SPACE. THE PHYSICIAN ALSO BELIEVED THAT PATIENTS NUMBNESS AND PAIN WAS NOT EFFECTED WITH SPINAL CORD STIMULATOR (SCS) WHETHER IF ITS ON OR OFF. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED LEAD WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141197 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7053265 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention