BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 10387091 · Received August 10, 2020

    Report

    Report Number
    3006630150-2020-03333
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    July 13, 2020
    Report Date
    August 10, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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-8216-50, SERIAL: (B)(4), BATCH: 7070538.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG SITE AND WAS CONFIRMED TO BE (B)(6). IT WAS UNKNOWN IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND WAS ADVICE TO KEPT IT CLEANED. THE PATIENT BELIEVED THAT THE BODY WAS DOING A GOOD JOB FIGHTING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849001 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 366339 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention