BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 10533985 · Received September 15, 2020

    Report

    Report Number
    3006630150-2020-04209
    Event Type
    Injury
    Date Received
    September 15, 2020
    Date of Event
    August 26, 2020
    Report Date
    September 15, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: SC-8216-50, MODEL: SC-8216-50, SERIAL: (B)(4), BATCH: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IPG AND LEAD ADJUSTMENT PROCEDURE DUE TO INADEQUATE PAIN RELIEF AND POOR PLACEMENT. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL DEVICES REMAIN IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998922 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 358174 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention