BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 10392135 · Received August 11, 2020

    Report

    Report Number
    3006630150-2020-03361
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    March 31, 2020
    Report Date
    August 11, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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-2352-50, SERIAL: (B)(4), BATCH: 5161351. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: (B)(4), MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 5134360. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: (B)(4), MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 5135299. PRODUCT FAMILY: SCS-IPG-R, UPN: (B)(4), MODEL: SC-1160, SERIAL: (B)(4), BATCH: 366028.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OCCASIONAL SHOCK FEELING RUNNING UP HER SPINE WHEN SHE SAT DOWN. THIS HAPPENED REGARDLESS OF STIMULATION BEING ON OR OFF. REPROGRAMMING WAS PERFORMED BUT DID NOT RESOLVE THE PROBLEM. THE PRESSURE PAIN WAS DUE TO WHERE THE LEADS WERE PLACED WHICH CAUSED PHYSICAL PRESSURE AT IMPLANT SITE. THE PATIENT UNDERWENT AN EXPLANT OF THE SCS SYSTEM AND WAS DOING WELL POST-OPERATIVELY. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THE PHYSICIAN DISPOSED OF THE EXPLANTED PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855666 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 5038733 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention