BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 10052409 · Received May 13, 2020

    Report

    Report Number
    3006630150-2020-02050
    Event Type
    Injury
    Date Received
    May 13, 2020
    Date of Event
    April 23, 2020
    Report Date
    May 13, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/ CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/ LOT NUMBER: 5040536, MODEL/ CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE LEAD SITE. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE ANCHOR WAS REPOSITIONED DEEPER. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515679 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5025579 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention