BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 9003076 · Received September 12, 2019

    Report

    Report Number
    3006630150-2019-04988
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    August 22, 2019
    Report Date
    September 12, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5143249/5149729, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WERE FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. SYMPTOMS OF FEVER, REDNESS, SWELLING, INFLAMMATION, AND LEAKING FROM THE INCISION SITE WERE NOTED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS BUT WERE NOT ABLE TO REDUCE INFECTION. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED AND THE CAUSE WAS PATIENTS HYGIENE. IT WAS MENTIONED THAT PATIENT DID NOT ALLOW THE SITE TO HEAL BEFORE RESUMING ACTIVITY AND DID NOT MAINTAIN DRESSING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803333 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 358256 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention