BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 11259500 · Received February 1, 2021

    Report

    Report Number
    3006630150-2021-00191
    Event Type
    Injury
    Date Received
    February 1, 2021
    Date of Event
    October 19, 2020
    Report Date
    February 1, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. (B)(4). 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: 7081162.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FEELING THE STIMULATION IN THE ABDOMEN AND RIBS AND WAS NOT GETTING STIMULATION TO THE TARGET AREA. IMAGES WAS TAKEN AND SHOWED LEAD MIGRATION. THE PATIENT HAD A REPROGRAMMING WITH NO IMPROVEMENT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE MOVED UP TO THE CORRECT LEVEL. THE PATIENT WAS DOING WELL POST OPERATIVELY. NOTHING WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156926 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7081080 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention