BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 9846573 · Received March 18, 2020

    Report

    Report Number
    3006630150-2020-01253
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    February 24, 2020
    Report Date
    March 18, 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

    MODEL NUMBER/CATALOG NUMBER: SC-2352-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5167902/ 7070048, MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 70 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE POCKET AND MIDLINE INCISION SITES. SYMPTOMS OF RED, IRRITATION AND PUSS COMING OUT WERE NOTED. THE PATIENT ALSO EXPERIENCED CHILLS AND FEVER. THE PHYSICIAN DID NOT BELIEVED THAT INFECTION WAS DEVICE OR PROCEDURE REATED. THE PATIENT WAS ADMINISTERED WITH INTRAVENOUS ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312268 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 364643 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention