BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 18271259 · Received December 5, 2023

    Report

    Report Number
    3006630150-2023-07624
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    September 16, 2023
    Report Date
    April 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 . MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7082251/7082327.

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED COUPLE OF MONTHS AGO BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS SOME INFECTION FROM THE BACK SURGERIES. SYMPTOMS OF PAIN WAS NOTED. PHYSICIAN THINKS THAT THE IPG IS ALSO INFECTED. ADDITIONAL INFORMATION WAS RECEIVED ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY. THE SYSTEM WAS SWABBED FOR INFECTION AND NONE WAS PRESENT. THE PATIENT WAS GIVEN AN ANTIBIOTIC TO ENSURE THERE WAS NOT GOING TO BE AN INFECTION. THE PATIENT WAS DOING FINE POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION FROM NON-DEVICE RELATED BACK SURGERIES. SYMPTOMS OF PAIN WAS NOTED. PHYSICIAN THINKS THAT THE IPG IS ALSO INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161184 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 370627 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention