BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 18997524 · Received March 28, 2024

    Report

    Report Number
    3006630150-2024-01879
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    February 14, 2024
    Report Date
    March 28, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2208500. MODEL: SC-2208-50. SERIAL: (B)(6). BATCH: 171912/A45211. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 228919/276276. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138550. MODEL: SC-3138-55. SERIAL: (B)(6). BATCH: 154543/160855.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS EXPERIENCING DIFFICULTY IN CHARGING THE IPG. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL DEVICE COMPONENTS WERE REMOVED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487591 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 177827

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention