BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 12244848 · Received July 29, 2021

    Report

    Report Number
    3006630150-2021-04201
    Event Type
    Injury
    Date Received
    July 29, 2021
    Date of Event
    August 2, 2020
    Report Date
    July 29, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED SIX MONTHS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 5155385/7070124.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FEELING A SHOCKING SENSATION AT THE IPG SITE OCCASIONALLY WHEN THE STIMULATOR WAS TURNED ON. IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE AND WAS NOT GETTING AN ADEQUATE PAIN RELIEF TO THE AREA WHERE THE STIMULATION SHOULD COVER. IT WAS FURTHER NOTED THAT HE IPG HAD TO BE CHARGED MORE FREQUENTLY. DATABASE ANALYSIS SHOWED SIGNS OF POOR CHARGER TO IPG COUPLING AND THE CHARGER THERMISTOR TRIGGERING OFTEN WHICH COULD DELAY CHARGING TIMES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND THE EXPLANTED SCS SYSTEM WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143231 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 368048 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention