BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 10600348 · Received September 29, 2020

    Report

    Report Number
    3006630150-2020-04509
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    September 9, 2020
    Report Date
    September 29, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. 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: 5144699/7050135. PRODUCT FAMILY: SCS-LEAD FIXATION: UPN: (B)(4), MODEL: SC-4316, BATCH: 23543444.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE AND THE INCISION WAS OPEN EXPOSING THE LEADS. THE INFECTION WAS NOT DEVICE RELATED AND THE CAUSE OF THE OPEN WOUND WAS UNKNOWN. ALL DEVICE COMPONENTS WERE EXPLANTED AND NOT RETURNED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063691 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 352818 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention