BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 18491188 · Received January 11, 2024

    Report

    Report Number
    3006630150-2023-08538
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    October 2, 2020
    Report Date
    January 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: 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: M365SC221850T0. MODEL: SC-2218-50T. SERIAL: (B)(6). BATCH: 204481/204527/209946/209811. PRODUCT FAMILY: SCS-IPG-R. UPN: M365SC1110020. MODEL: SC-1110-02. SERIAL: (B)(6). BATCH: 180198.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY IN CHARGING THE IPG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE TWO IPGS AND LEADS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731885 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 181094 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention