BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 9501309 · Received December 20, 2019

    Report

    Report Number
    3006630150-2019-07510
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    December 3, 2019
    Report Date
    December 19, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2317-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5151337, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 70CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION ON THE RIGHT SIDE. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY WITH GOOD COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300581 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5122290 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention