BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 10776972 · Received November 3, 2020

    Report

    Report Number
    3006630150-2020-05309
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    October 8, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7071043 / 7071066 / 7071098 / 7071100 / 7071107.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUNNELING OF THE PATIENTS LEADS HAD CAUSED SOME PULLING AT THE SKIN. IT WAS NOTED THAT THE PATIENTS LEADS WERE TUNNELED DOWN THE NECK INTO THE BACK WHERE THE IPG IS LOCATED. THE PATIENT DID NOT HAVE A FULL RANGE OF MOTION WITHOUT FEELING LIKE THE LEADS WERE PULLING WHEN MOVING THE NECK. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN AN EXTENSION WAS ADDED AND NOTHING WAS REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243736 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 7072028 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention