BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 11541518 · Received March 22, 2021

    Report

    Report Number
    3006630150-2021-01126
    Event Type
    Injury
    Date Received
    March 22, 2021
    Date of Event
    October 5, 2020
    Report Date
    April 6, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, BATCH: 23543367.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD PERSISTENT MYOFASCIAL PAIN AND THE IPG WAS CAUSING SIGNIFICANT DISCOMFORT. INADEQUATE STIMULATION WAS ALSO REPORTED. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO DISCOMFORT AT THE ANCHOR SITE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 5132811/7070019.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PERSISTENT MYSOFASCIAL PAIN AND THE IPG WAS CAUSING SIGNIFICANT DISCOMFORT. INADEQUATE STIMULATION WAS ALSO REPORTED. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444067 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 371197 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention