BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 8026572 · Received October 31, 2018

    Report

    Report Number
    3006630150-2018-61558
    Event Type
    Injury
    Date Received
    October 31, 2018
    Date of Event
    October 8, 2018
    Report Date
    October 31, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5020135, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. MODEL NUMBER/CATALOG NUMBER: SC-8216-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 19085054, MODEL/CATALOG DESCRIPTION: ARTISAN LEAD 70 CM. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS LEADS HAD MIGRATED AND WAS CAUSING UNWANTED STIMULATION IN THE NECK. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN ONE LEAD WAS REPLACED AS IT WAS DAMAGED PRESUMABLY FROM A RECENT FALL AND THE OTHER LEAD WAS REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865901 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 21505469 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention