BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 10889011 · Received November 23, 2020

    Report

    Report Number
    3006630150-2020-05766
    Event Type
    Injury
    Date Received
    November 23, 2020
    Date of Event
    October 14, 2020
    Report Date
    November 23, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    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-2366-70, SERIAL: (B)(4), BATCH: 7070255. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7071519.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A NON-DEVICE RELATED FUSION AND THE PERIPHERAL LEADS WERE IMPINGING ON SOME OF THE SCREWS THAT WERE IMPLANTED, AND FELT AS IF THEY WERE RUBBING AGAINST THE NEW HARDWARE. IT WAS NOTED THAT THE PATIENTS LEADS DID NOT MIGRATE. IN AN EFFORT TO PROVIDE MORE COMFORT FOR THE PATIENT, THE PATIENT UNDERWENT A LEAD REPOSITIONING PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. NO DEVICES WERE IMPLANTED OR EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351868 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 5071377 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention