BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 18692534 · Received February 12, 2024

    Report

    Report Number
    3006630150-2024-00647
    Event Type
    Injury
    Date Received
    February 12, 2024
    Date of Event
    October 1, 2023
    Report Date
    February 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2023. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 5110266/7079923.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD COMPLICATIONS FROM A NON-DEVICE RELATED SPINAL SURGERY AND DEVELOPED AN INFECTION ON THE SPINAL CORD STIMULATOR EQUIPMENT. ALL DEVICE COMPONENTS WERE COMPROMISED, AND THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806143 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 370655 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention