BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 8282124 · Received January 28, 2019

    Report

    Report Number
    3006630150-2019-00252
    Event Type
    Injury
    Date Received
    January 28, 2019
    Date of Event
    January 10, 2019
    Report Date
    February 27, 2019
    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
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE ANALYSIS ON THE EXPLANTED IPG SC-1200 SERIAL (B)(4) PASSED THE FUNCTIONAL TEST AND REVEALED NO ANOMALIES. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS SC-2408-56, SERIAL NUMBER (B)(4) AND CLIK ANCHOR SC-2408-56 LOT 21738706 REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD THE ENTIRE SYSTEM EXPLANTED AS IT WAS NOT HELPING HER PAIN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT DEVICES: REFERENCE NUMBER: 10541608, PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: (B)(4), MODEL: SC-2408-56, (B)(4). REFERENCE NUMBER: 10541694, PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: (B)(4), MODEL: SC-2408-56, (B)(4). REFERENCE NUMBER: 10541756, PRODUCT FAMILY: SCS-LEAD FIXATION-MRI, UPN: (B)(4), MODEL: SC-4319, BATCH: 21738706. THE IPG IS EN ROUTE TO BSN. IT IS INDICATED THAT THE LEADS AND CLIK ANCHOR WILL NOT BE RETURNED FOR EVALUATION AND THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD THE ENTIRE SYSTEM EXPLANTED AS IT WAS NOT HELPING HER PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76222 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 351910 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention