BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 10697222 · Received October 19, 2020

    Report

    Report Number
    3006630150-2020-04934
    Event Type
    Injury
    Date Received
    October 19, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 19, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2366-50, SERIAL:(B)(4), BATCH: 5072572. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 3056886. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 5001256.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PAIN AREA MOVED, AND THE PATIENT WAS RECEIVING INEFFECTIVE THERAPY. IN ADDITION, THE PATIENT'S PAIN IN THE UPPER PORTION OF THE BODY WAS NOT ADEQUATE. THE PATIENT UNDERWENT A REVISION PROCEDURE AND TWO OF THE LEADS WERE REPOSITIONED AND THE THIRD AND FOURTH LEADS WERE EXPLANTED. THE PATIENT IS DOING WELL POST-OPERATIVELY AND IS NOW RECEIVING COVERAGE IN THE PAIN AREAS. THE EXPLANTED LEADS WERE DISCARDED DUE TO HOSPITAL REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164171 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 5071374 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention