BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 17806458 · Received September 25, 2023

    Report

    Report Number
    3006630150-2023-05802
    Event Type
    Injury
    Date Received
    September 25, 2023
    Date of Event
    April 12, 2023
    Report Date
    October 20, 2023
    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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500/M365SC2218700. MODEL: SC-2218-50/2218-70. SERIAL: (B)(6). BATCH: 7081161/7074860.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BAD HEADACHES, DIARRHEA AND CONSTANT URINATION. AS A RESULT, THE PATIENT HAS BEEN IN AND OUT OF THE HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DOES NOT BELIEVE THAT PATIENTS SYMPTOMS WERE DEVICE RELATED. ALL DEVICE COMPONENTS WERE EXPLANTED AND WERE NOT RETURNED DUE TO FACILITY POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BAD HEADACHES, DIARRHEA AND CONSTANT URINATION. AS A RESULT, THE PATIENT HAS BEEN IN AND OUT OF THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1835204 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 371088 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Hospitalization| R