BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 8270204 · Received January 23, 2019

    Report

    Report Number
    3006630150-2019-00162
    Event Type
    Injury
    Date Received
    January 23, 2019
    Date of Event
    January 7, 2019
    Report Date
    January 23, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8216-70. SERIAL NUMBER: (B)(4). BATCH/LOT NUMBER: 14631075. MODEL/CATALOG DESCRIPTION: ARTISAN LEAD 70 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEAD 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. IT WAS MENTIONED THAT THE PATIENT WAS ABLE TO FEEL AND SEE THE EDGES OF THE IPG. THE PHYSICIAN BELIEVED THAT THE CAUSE OF INFECTION WAS GAB IN SUTURES OR CLOSURE OF THE SKIN AFTER A RECENT REVISION (MFR REPORT NUMBER 3006630150-2018-62637). THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64855 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 357878 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention