BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 20800837 · Received November 27, 2024

    Report

    Report Number
    3006630150-2024-08204
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    October 13, 2022
    Report Date
    November 27, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216700 MODEL: SC-8216-70 SERIAL: (B)(6). BATCH: 7070634.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF DESPITE REPROGRAMMING. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) PROCEDURE WHEREIN ALL DEVICES WERE EXPLANTED. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2453072 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 374541 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention