BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 11222965 · Received January 25, 2021

    Report

    Report Number
    3006630150-2021-00125
    Event Type
    Injury
    Date Received
    January 25, 2021
    Date of Event
    January 5, 2021
    Report Date
    January 25, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789567
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7070340.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AND LIMITED RANGE OF MOTION IN THE NECK FROM THE LEADS THAT WERE TUNNELED. THE PHYSICIAN ADJUSTED THE TUNNELED LEADS AND THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119749 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 7070336 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention