BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 18335273 · Received December 15, 2023

    Report

    Report Number
    3006630150-2023-07872
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    November 20, 2023
    Report Date
    December 9, 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
    MA, 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-MRI. UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6), BATCH: 7072105/7072134.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING SIGNIFICANT RELIEF FROM THE SPINAL CORD STIMULATION (SCS) OR INJECTIONS. THE PATIENT WAS REQUIRED MEDICATION AND TAKING OXYCODONE-ACETAMINOPHEN. THE PATIENT IS NOW HAVING INCREASED PAIN OVER THE IPG AND WILL UNDERGO REVISION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING SIGNIFICANT RELIEF FROM SCS OR INJECTIONS. THE PATIENT WAS REQUIRED MEDICATION AND TAKING OXYCODONE-ACETAMINOPHEN. THE PATIENT IS NOW HAVING INCREASED PAIN OVER THE IPG. ADDITIONAL INFORMATION RECEIVED THAT PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE ALL DEVICES WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052703 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 372854 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention