BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 9492882 · Received December 19, 2019

    Report

    Report Number
    3006630150-2019-07459
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    December 3, 2019
    Report Date
    February 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
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS INFECTION WAS SUPERFICIAL AND THE PHYSICIAN CONFIRMED THAT IT WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENTS WOUNDS WERE HEALING AND LESS DRAINAGE HAD BEEN NOTED. THE PATIENT WAS REPORTEDLY DOING WELL.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE ANTIBIOTICS THAT THE PATIENT TOOK WAS NOT HELPING. THE PATIENT WAS SCHEDULED FOR EXPLANT, HOWEVER, THE PHYSICIAN DID NOT SEE ANY SIGNS AND SYMPTOMS DEEPER THAN THE TOPICAL INFECTION UPON OPENING UP THE MIDLINE INCISION AND IPG SITE. THE PHYSICIAN OPTED TO KEEP THE DEVICE IMPLANTED AS NO MALFUNCTION WAS SUSPECTED. THE PHYSICIAN TREATED THE INCISION SITES WITH VANCOMYCIN POWDER AND CLOSED IT UP. UPON FOLLOW-UP, THE INFECTION WAS CLEARING UP AND THE INCISION SITES WERE IMPROVING. THE PATIENT WAS REPORTEDLY DOING WELL.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT WAS SUSPECTED TO HAVE AN INFECTION. SYMPTOM OF DRAINAGE FROM BOTH INCISION SITES WAS NOTED. THE PATIENT WAS PLACED ON ANTIBIOTIC.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT WAS SUSPECTED TO HAVE AN INFECTION. SYMPTOM OF DRAINAGE FROM BOTH INCISION SITES WAS NOTED. THE PATIENT WAS PLACED ON ANTIBIOTIC.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/ CATALOG NUMBER: SC-8416-70, SERIAL NUMBER: (B)(4), BATCH/ LOT NUMBER: 7013078, MODEL/ CATALOG DESCRIPTION: ARTISAN MRI PADDLE LEAD 70 CM. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES 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 WAS SUSPECTED TO HAVE AN INFECTION. SYMPTOM OF DRAINAGE FROM BOTH INCISION SITES WAS NOTED. THE PATIENT WAS PLACED ON ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293656 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 361396 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention