BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 16542319 · Received March 14, 2023

    Report

    Report Number
    3006630150-2023-01271
    Event Type
    Injury
    Date Received
    March 14, 2023
    Date of Event
    October 6, 2022
    Report Date
    March 14, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(4), BATCH: 7072512. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL:(B)(4) , BATCH: 7071960.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT LOST WEIGHT AND AS RESULT THE IMPLANTABLE PULSE GENERATOR (IPG) BECAME TOO SHALLOW TO BE ABLE TO CHARGE EFFICIENTLY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG WAS REPOSITIONED TO THE OTHER SIDE OF THE PATIENT'S BODY. BECAUSE THE IPG WAS MOVED, THE LEADS WERE ALSO RE-TUNNELED TO THE OTHER SIDE. POST OPERATIVELY, THE PATIENT WAS RECOVERING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051093 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 375848 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention