BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 10303591 · Received July 21, 2020

    Report

    Report Number
    3006630150-2020-03012
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    July 3, 2020
    Report Date
    July 21, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2218-70, SERIAL:(B)(4), BATCH: 5164800. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2218-70, SERIAL:(B)(4), BATCH: 5163121. PRODUCT FAMILY: SCS-LINEAR FIXATION: UPN: (B)(4), MODEL: SC-4318, BATCH: 24704690.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SWELLING, PUS AND PAIN AT THE POCKET SITE. CULTURES WERE TAKEN, AND IT WAS FOUND THAT A SKIN GERM HAD GOTTEN INTO THE WOUND THROUGH SWEATING AS PATIENT CONTINUED TO WORK AS A FARMER POST-IMPLANT PROCEDURE. PATIENT UNDERWENT AN EXPLANT PROCEDURE TO HAVE THE DEVICE REMOVED, AND WAS PLACED ON ANTIBIOTICS. PATIENT HAS FULLY RECOVERED POST-EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765400 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 366464 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention