BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 10292957 · Received July 17, 2020

    Report

    Report Number
    3006630150-2020-02985
    Event Type
    Injury
    Date Received
    July 17, 2020
    Date of Event
    July 2, 2020
    Report Date
    July 17, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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-2352-50, SERIAL: (B)(4), BATCH: 7070304.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION AS A RESULT OF LEAD MIGRATION. THE LEAD THAT MIGRATED WAS EXPLANTED AS THE ATTEMPT TO PLACE IT INTO THE CORRECT AREA WAS UNSUCCESSFUL. THE OTHER LEAD WAS THEN REPOSITIONED TO CAPTURE STIMULATION COVERAGE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755698 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 5071347 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention