BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 17438029 · Received August 1, 2023

    Report

    Report Number
    3006630150-2023-04492
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    January 1, 2020
    Report Date
    August 1, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6), BATCH: 7070251.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED MUSCLE SPASMS AT THE BACK AND HAD PAIN WHETHER THE STIMULATION WAS ON OR OFF. IT WAS ALSO NOTED THAT THE PATIENT HAD DIFFICULTY ALIGNING THE IPG TO THE CHARGER. X-RAY WAS TAKEN AND SHOWED THAT THERE WAS LEAD MIGRATION AS WELL. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISPOSED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809574 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 366911 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention