BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 9365156 · Received November 22, 2019

    Report

    Report Number
    3006630150-2019-06735
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 22, 2019
    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-8216-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7051720, MODEL/CATALOG DESCRIPTION: ARTISAN LEAD 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. 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 DEVELOPED AN INFECTION AROUND THE IPG SITE. SYMPTOM OF PUS COMING FROM THE OPENING AROUND THE BATTERY SITE WAS NOTED. PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE NOR PROCEDURE RELATED BUT WAS UNKNOWN WHAT CAUSED IT. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158070 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 361322 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention