BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 10748604 · Received October 28, 2020

    Report

    Report Number
    3006630150-2020-05216
    Event Type
    Injury
    Date Received
    October 28, 2020
    Date of Event
    September 29, 2020
    Report Date
    November 25, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE PATIENTS LEAD HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE AND THE LEAD REMAINS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT PRIOR TO THE LEAD REVISION PROCEDURE, THE PATIENT WAS UNABLE TO GET ADEQUATE LEFT SIDED COVERAGE.

    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-2218-50, SERIAL: (B)(4), BATCH: 7081203.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE PATIENTS LEAD HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE AND THE LEAD REMAINS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210774 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7081129 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention