BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 17254531 · Received July 5, 2023

    Report

    Report Number
    3006630150-2023-03867
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    September 1, 2022
    Report Date
    July 25, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED SOMETIME IN (B)(6) 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. (B)(6). BATCH: 7092540/7091321.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF AND DISCOMFORT FROM THE IPG SITE WHEN SLEEPING ON THE SIDE. IT WAS ALSO NOTED THAT A LEAD WAS DISPLACED WHICH WAS CONFIRMED THROUGH X-RAY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF AND DISCOMFORT FROM THE IPG SITE WHEN SLEEPING ON THE SIDE. IT WAS ALSO NOTED THAT A LEAD WAS DISPLACED WHICH WAS CONFIRMED THROUGH X-RAY. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1775004 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 375050 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention