BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 9717224 · Received February 17, 2020

    Report

    Report Number
    3006630150-2020-00609
    Event Type
    Injury
    Date Received
    February 17, 2020
    Date of Event
    January 29, 2020
    Report Date
    February 17, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8216-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7022591, MODEL/CATALOG DESCRIPTION: ARTISAN LEAD 70 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A WEEK AFTER AN IMPLANT PROCEDURE, THE PATIENT DEVELOPED AN ALLERGIC REACTION TO THE TAPE THAT WAS USED TO COVER THE IPG AND LEAD INCISION SITES. THE PHYSICIAN BELIEVED IT WAS NOT DEVICE RELATED AND NO INFECTION WAS NOTED. THE PATIENT WAS PRESCRIBED WITH PREVENTIVE ANTIBIOTICS AND ALLERGY MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181375 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 365483 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention