BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 10169273 · Received June 18, 2020

    Report

    Report Number
    3006630150-2020-02521
    Event Type
    Injury
    Date Received
    June 18, 2020
    Date of Event
    May 28, 2020
    Report Date
    June 18, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-20, SERIAL: (B)(4), BATCH: 5171322.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS LEADS MIGRATED AFTER A NON-DEVICE RELATED HOSPITALIZATION WHICH WAS VERIFIED THROUGH X-RAY. IT WAS ALSO NOTED THAT THE PATIENT WAS ONLY RECEIVING UNILATERAL COVERAGE. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS REPROGRAMMED POSTOPERATIVE AND WAS RECEIVING BILATERAL COVERAGE. THE EXPLANTED DEVICES WERE NOT RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632174 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5170671 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention