BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 14374542 · Received May 12, 2022

    Report

    Report Number
    3006630150-2022-02194
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    April 1, 2022
    Report Date
    May 12, 2022
    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
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 5069782, PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 5070917.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND DISCOMFORT DUE TO THE IMPLANTABLE PULSE GENERATOR IPG MIGRATING TOWARD THE LEFT HIP AND THE LEADS HAD MIGRATED CAUSING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG AND LEADS WERE EXPLANTED. THE PHYSICIAN ASSESSED WHILE EXPLANTING THE DEVICES THAT THERE WAS SCARRING THAT ALSO CONTRIBUTED TO THE PATIENT'S PAIN. THE PATIENT WAS EXPECTED TO FULLY RECOVER POST-OPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE FACILITY AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114232 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 357008 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention