BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 13549462 · Received February 17, 2022

    Report

    Report Number
    3006630150-2022-00563
    Event Type
    Injury
    Date Received
    February 17, 2022
    Date of Event
    January 1, 2017
    Report Date
    February 17, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED IN 2017. EXPLANT DATE: 2017. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2138500, MODEL: SC-2138-50, SERIAL: (B)(4), BATCH: 163258/A24870/165579/A25371.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE PATIENT WAS CURRENTLY DOING WELL. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566974 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 101381

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention