BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 9846528 · Received March 18, 2020

    Report

    Report Number
    3006630150-2020-01251
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    September 23, 2019
    Report Date
    March 18, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2317-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7042039, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO HIGH IMPEDANCE AND MIGRATION. IT WAS ALSO NOTED THAT THE LEADS WERE FRACTURED DUE TO POSSIBLE HEMATOMA. THE PATIENT UNDERWENT LEADS REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310814 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5134084 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention