BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 10795277 · Received November 5, 2020

    Report

    Report Number
    3006630150-2020-05388
    Event Type
    Injury
    Date Received
    November 5, 2020
    Date of Event
    October 15, 2020
    Report Date
    November 5, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: (B)(4); MODEL: SC-2408-74; SERIAL: (B)(4); BATCH: 7071564/7071579. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LEAD FIXATION-MRI; UPN: (B)(4); MODEL: SC-4319; SERIAL: (B)(4); BATCH: 25254149.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE CERVICAL INCISION SITE. SYMPTOMS OF PAIN AND LEAKAGE AT THE SITE WERE NOTED. IT WAS UNKNOWN IF THE INFECTION WAS DEVICE RELATED, HOWEVER, IT WAS NOT PROCEDURE RELATED. THE CAUSE OF INFECTION WAS ALSO UNKNOWN. THE PATIENT WAS PLACED ON ORAL ANTIBIOTICS, AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL DEVICE COMPONENTS WERE EXPLANTED, AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256649 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 354131 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention