BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 11065194 · Received December 23, 2020

    Report

    Report Number
    3006630150-2020-06361
    Event Type
    Injury
    Date Received
    December 23, 2020
    Date of Event
    August 19, 2020
    Report Date
    December 23, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: (B)(4), MODEL: SC-8216-70, SERIAL: (B)(4), BATCH: 7033740.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING AN EXCRUCIATING ABDOMINAL PAIN EVEN WHEN THE DEVICE WAS TURNED OFF. IT WAS ALSO STATED THAT THE PATIENT WAS EXPERIENCING UNDESIRED SENSATIONS ON NON TARGETED AREAS AND WEAKNESS ON HER LEGS. ISSUES WERE NOT ABLE TO RESOLVED BY REPROGRAMMING. THE PATIENT WAS HAVING DISCOMFORT AT THE IPG SITE. ALL DEVICE COMPONENTS WERE EXPLANTED AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527765 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 370034 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention