BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 14476790 · Received May 23, 2022

    Report

    Report Number
    3006630150-2022-02406
    Event Type
    Injury
    Date Received
    May 23, 2022
    Date of Event
    May 3, 2022
    Report Date
    May 23, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2208500; MODEL: SC-2208-50; SERIAL: (B)(4); BATCH: 190372/190363.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION DESPITE REPROGRAMMING DONE. ALL DEVICE COMPONENTS WERE EXPLANTED AND WERE NOT RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488804 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 176846

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention