BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 20262712 · Received September 19, 2024

    Report

    Report Number
    3006630150-2024-06278
    Event Type
    Injury
    Date Received
    September 19, 2024
    Date of Event
    April 24, 2024
    Report Date
    September 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R UPN: M365SC11100, MODEL: SC-1110, SERIAL: (B)(6), BATCH: 177383. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2208500, MODEL: SC-2208-50, SERIAL: (B)(6), BATCH: 192174/192196.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT HOLDING A CHARGE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223027 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 20616374 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Required Intervention