BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIK X MRI

    MDR report key: 11675870 · Received April 15, 2021

    Report

    Report Number
    3006630150-2021-01600
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    March 18, 2021
    Report Date
    April 15, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905325
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 7071131. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 7071150. PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12000, MODEL: SC-1200, SERIAL: (B)(4), BATCH: 369748.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CLIK ANCHOR THAT HAD PROTRUDED AND A BED SORE WAS CONFIRMED AROUND THAT AREA. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE ENTIRE SPINAL CORD STIMULATOR SYSTEM IN CONSIDERATION OF THE RISK OF INFECTION. THE PHYSICIAN STATED THAT THE PATIENT HAD EXPERIENCED WEIGHT LOSS AND THERE IS NO RELATION BETWEEN THE IMPLANTED DEVICES AND THIS EVENT. NO INFECTION WAS OBSERVED DURING THE EXPLANT PROCEDURE. ALL EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567341 CLIK X MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-4319 25254149 08714729905325

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention