BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 15653308 · Received October 21, 2022

    Report

    Report Number
    3006630150-2022-05682
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    September 26, 2022
    Report Date
    October 21, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729784067
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC221850E0. MODEL: SC-2218-50E. SERIAL: (B)(4). BATCH: 7102723.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRIAL PROCEDURE, THE PATIENT DEVELOPED NEW PAIN AT THE LEFT SHOULDER THAT INCREASED OVER THE COURSE OF THE TRIAL. THE PHYSICIAN BELIEVED THAT THE SCAR TISSUE OR ADHESIONS WERE IRRITATED DURING LEAD INSERTION CAUSING NEW PAIN. THE PATIENT HAD A LEAD PULL AND IMMEDIATELY FELT BETTER. THE EXPLANTED LEAD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2240923 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E 7083613 08714729784067

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention